PENTAX Medical OE-A63Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 14961333232991), received between Mar 30, 2023 and Jan 22, 2026 — classified as 28 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2026Material Separation

  ON 12-DEC-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP, LOT NUMBER 0021124 IN GERMANY WITHIN THE EMEA REGION. DURING A DUODENOSCOPY, A SINGLE-USE STERILE DISTAL END CAP (DEC) CAME OFF AND FELL INTO THE PATIENT'S BODY. THE DETACHED DEC WAS RETRIEVED FROM THE PATIENT'S BODY, AND NO HARM OCCURRED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142957 ↗
• InjuryJan 8, 2026Material Separation; Device Dislodged or Dislocated

  REFER TO H11

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003266 ↗
• InjuryNov 6, 2025Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  ON 22-OCT-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP, LOT NUMBER 0011114 IN SWITZERLAND WITHIN THE EMEA REGION. DURING AN ENDOSCOPIC PROCEDURE, THE DISTAL END CAP (DEC) DETACHED AND REMAINED INSIDE THE PATIENT'S BODY. THE DEC IS A SINGLE-USE STERILE COMPONENT. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE DEC, BUT NO PATIENT HARM OCCURRED. ACCORDING TO THE USER FACILITY, SIMILAR INCIDENTS IN WHICH THE DEC DETACHED FROM THE DISTAL END OF THE ENDOSCOPE HAD OCCURRED MULTIPLE TIMES IN THE PAST. HOWEVER, IN THOSE CASES, THE DEC WAS REMOVED WITHOUT REQUIRING ANY ADDITIONAL PROCEDURE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23493554 ↗
• InjuryNov 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REFER TO H11.

  Patient problems: Foreign Body In Patient

  MAUDE report 23487673 ↗
• InjuryOct 15, 2025Material Separation; Material Separation

  REFER TO H11.

  Patient problems: Foreign Body In Patient

  MAUDE report 23305599 ↗
• InjuryAug 29, 2025Material Separation; Material Separation

  ON 06-AUG-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0021124 IN CANADA WITHIN THE PAI REGION. THE BILIARY STENT COULD NOT BE DEPLOYED USING A DUODENOSCOPE. WHEN A PAPILLOTOME WAS INSERTED FOR CONFIRMATION, RESISTANCE WAS NOTED, AND UPON WITHDRAWING THE ENDOSCOPE AND CHECKING THE DISTAL END, IT WAS FOUND THAT THE SINGLE-USE STERILE DISTAL END CAP (DEC) WAS DIVIDED INTO THREE PIECES. THE PROCEDURE WAS COMPLETED BY SWITCHING TO AN ALTERNATIVE ENDOSCOPE, BUT THE PROCEDURE TIME WAS PROLONGED AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO PATIENT HARM. AT THE FACILITY, A CLICK SOUND HAD BEEN CONFIRMED WHEN ATTACHING THE DEC. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921267 ↗
• InjuryAug 17, 2025Material Separation; Material Separation

  ON 06-AUG-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL SINGLE USE STERILE DISTAL END CAP MODEL OE-A63 IN CANADA WITHIN THE PAI REGION. A SINGLE-USE STERILE DISTAL END CAP (DEC) FOR A DUODENOSCOPE WAS ATTACHED TO THE DISTAL END OF THE ENDOSCOPE, AND AN INSPECTION WAS CONDUCTED ACCORDING TO THE PRE-USE INSPECTION PROCEDURE. WHEN ATTACHING THE DEC, TWO STAFF MEMBERS CONFIRMED THE CLICKING SOUND, AND THE PHYSICIAN VISUALLY CONFIRMED IT BEFORE INSERTING THE ENDOSCOPE INTO THE PATIENT. SUBSEQUENTLY, WHEN THE PHYSICIAN ATTEMPTED TO OPERATE THE FORCEPS ELEVATOR, THE DEC DETACHED FROM THE DISTAL END OF THE ENDOSCOPE AND FELL INTO THE PATIENT'S BODY. THE PHYSICIAN RETRIEVED THE DEC USING BASKET FORCEPS FOR A GASTROSCOPE AND COMPLETED THE PROCEDURE WITH ANOTHER DUODENOSCOPE. THERE WAS NO PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22824526 ↗
• InjuryAug 15, 2025Material Separation; Device Dislodged or Dislocated; Material Separation; Device Dislodged or Dislocated

  REFER TO H11.

  Patient problems: Foreign Body In Patient

  MAUDE report 22820096 ↗
• MalfunctionJul 17, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON 24-JUN-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0021015 IN GERMANY WITHIN THE EMEA REGION, UPON RECEIVING AN INVESTIGATION REQUEST FROM THE GERMAN AUTHORITY REGARDING THE PRODUCT. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE ELEVATOR OF THE DEC BROKE TWICE. AS A RESULT, THE ANGULATION OF THE CHOLANGIOSCOPE COULD NOT BE ADJUSTED WITHIN THE BILE DUCT, AND APPROPRIATE POSITIONAL CONTROL WAS NOT POSSIBLE. ALTHOUGH THE DEC WAS REPLACED SEVERAL TIMES, THE CHOLANGIOSCOPE BECAME CAUGHT IN THE BROKEN ELEVATOR, MAKING IT DIFFICULT TO REMOVE THE CHOLANGIOSCOPE FROM THE INSTRUMENT CHANNEL. CONSEQUENTLY, THE SHEATH AT THE DISTAL END OF THE CHOLANGIOSCOPE WAS DAMAGED. DUE TO THIS ISSUE, THE TREATMENT METHOD WAS CHANGED TO MECHANICAL LITHOTRIPSY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528694 ↗
• MalfunctionJul 17, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON 24-JUN-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0021015 IN GERMANY WITHIN THE EMEA REGION, UPON RECEIVING AN INVESTIGATION REQUEST FROM THE GERMAN AUTHORITY REGARDING THE PRODUCT. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE ELEVATOR OF THE DEC BROKE TWICE. AS A RESULT, THE ANGULATION OF THE CHOLANGIOSCOPE COULD NOT BE ADJUSTED WITHIN THE BILE DUCT, AND APPROPRIATE POSITIONAL CONTROL WAS NOT POSSIBLE. ALTHOUGH THE DEC WAS REPLACED SEVERAL TIMES, THE CHOLANGIOSCOPE BECAME CAUGHT IN THE BROKEN ELEVATOR, MAKING IT DIFFICULT TO REMOVE THE CHOLANGIOSCOPE FROM THE INSTRUMENT CHANNEL. CONSEQUENTLY, THE SHEATH AT THE DISTAL END OF THE CHOLANGIOSCOPE WAS DAMAGED. DUE TO THIS ISSUE, THE TREATMENT METHOD WAS CHANGED TO MECHANICAL LITHOTRIPSY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528693 ↗
• InjuryApr 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21786406 ↗
• InjuryApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 19-MAR-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A MODEL: OE-A63, LOT NUMBER: 0011083 STERILE DISTAL END CAP(DEC) IN GERMANY WITHIN EMEA REGION. DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE SINGLE-USE STERILE DISTAL END CAP BECAME LOOSE AND DETACHED FROM THE DISTAL END OF THE ENDOSCOPE. A SENIOR SERVICE MANAGER FROM PENTAX MEDICAL INSPECTED THE ATTACHMENT AND REMOVAL OF THE DEC ON-SITE AND FOUND NO ABNORMALITIES WITH THE DUODENOSCOPE OR THE DEC. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21770110 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THE OE-A63 STERILE DISTAL END CAP CAME OFF INSIDE OF THE PATIENT'S STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 STERILE DISTAL END CAP. THIS WAS NOT REPORTED PREVIOUSLY BY THE USER FACILITY'S ENDOSCOPY TECHNICIAN SUPERVISOR. THE EXACT DATE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 22 MONTHS AGO (B)(6) 2022). THE CUSTOMER ALSO DID NOT RECORD ANY OF THE LOT NUMBERS IN ANY OF THE PATIENT CHARTS WHEN THIS OCCURRED. AT THIS TIME THEY DO NOT HAVE TRACEABILITY ON THE DECS LOT NUMBERS USED. PER THE ACCOUNT, THEY ONLY HAVE TWO LOT NUMBERS OF STERILE DISTAL END CAP MODEL #: OE-A63 ON SITE. LOT #: 0011112 & 0021122. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 22 MONTH AGO (B)(6) 2022). THEREFORE, THE B3 DATE OF EVE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18882953 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THE OE-A63 STERILE DISTAL END CAP CAME OFF INSIDE OF THE PATIENT'S MOUTH, HOWEVER, THEY WERE ABLE TO RETRIEVE THE STERILE DISTAL END CAP. THIS WAS NOT REPORTED PREVIOUSLY BY THE USER FACILITY'S ENDOSCOPY TECHNICIAN SUPERVISOR. THE EXACT DATE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 22 MONTHS AGO (APRIL 2022). THE CUSTOMER ALSO DID NOT RECORD ANY OF THE LOT NUMBERS IN ANY OF THE PATIENT CHARTS WHEN THIS OCCURRED. AT THIS TIME THEY DO NOT HAVE TRACEABILITY ON THE DECS LOT NUMBERS USED. PER THE ACCOUNT, THEY ONLY HAVE TWO LOT NUMBERS OF STERILE DISTAL END CAP MODEL #: OE-A63 ON SITE. LOT #: 0011112 & 0021122. THEREFORE, THE D4 LOT NUMBER IS LISTED AS #: 0011112 AND 0021122, TWO LOT NUMBERS. ADDITIONALLY THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18882951 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THE OE-A63 STERILE DISTAL END CAP CAME OFF INSIDE OF THE PATIENT'S MOUTH, HOWEVER, THEY WERE ABLE TO RETRIEVE THE STERILE DISTAL END CAP. THIS WAS NOT REPORTED PREVIOUSLY BY THE USER FACILITY'S ENDOSCOPY TECHNICIAN SUPERVISOR. THE EXACT DATE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 2 MONTHS AGO (B)(6) 2023). THE CUSTOMER ALSO DID NOT RECORD ANY OF THE LOT NUMBERS IN ANY OF THE PATIENT CHARTS WHEN THIS OCCURRED. AT THIS TIME THEY DO NOT HAVE TRACEABILITY ON THE DECS LOT NUMBERS USED. PER THE ACCOUNT, THEY ONLY HAVE TWO LOT NUMBERS OF STERILE DISTAL END CAP MODEL #: OE-A63 ON SITE. LOT #: 0011112 & 0021122. ADDITIONALLY THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 2 MONTH AGO (B)(6)

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18882949 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18879720 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18879712 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFER TO H11.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18879670 ↗
• InjuryMar 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE OE-A63 STERILE DISTAL END CAP FELL OFF INTO THE PATIENT'S STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 STERILE DISTAL END CAP. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 1 MONTH AGO ((B)(6) 2024). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS (B)(6) 2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18872283 ↗
• InjuryMar 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE OE-A63 STERILE DISTAL END CAP FELL OFF INTO THE PATIENT'S STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 STERILE DISTAL END CAP. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 6 MONTHS AGO ((B)(6) 2023). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS 01-JAN-2023. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18872279 ↗
• InjuryMar 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 22-FEB-2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THEIR PATIENT SPAT OUT FROM THEIR MOUTH THE OE-A63 STERILE DISTAL END CAP. THE PHYSICIAN ATTACHED THE OE-A63 TO THE ED34-I10T2 DUODENOSCOPE PRIOR TO THE PROCEDURE START. HOWEVER, THE PROCEDURE WAS ABLE TO BE PERFORMED TO COMPLETION, WITHOUT ANY ISSUES DURING THE CASE. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18872278 ↗
• InjuryMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE OE-A63 STERILE DISTAL END CAP FELL OFF INTO THE PATIENT'S STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 STERILE DISTAL END CAP. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 1 MONTH AGO (JANUARY 2024). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS 01-JAN-2024. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18861780 ↗
• InjuryMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE OE-A63 STERILE DISTAL END CAP FELL OFF INTO THE PATIENT'S STOMACH. THEY HAD TO STOP THE PROCEDURE, IN ORDER TO RETRIEVE THE OE-A63 STERILE DISTAL END CAP. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. B3: THE EXACT DATE OF OCCURENCE IS UNKNOWN AT THIS TIME, BUT CUSTOMER STATED IT WAS APPROXIMATELY 6 MONTHS AGO ((B)(6) 2023). THEREFORE, THE B3 DATE OF EVENT WAS LISTED AS 01-JAN-2023. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18861777 ↗
• InjuryMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2024 THAT OCCURRED DURING TREATMENT IN THE UNITED STATES INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP(DEC) MODEL OE-A63, LOT NUMBER 0011112 OR 0021122. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT AFTER A PROCEDURE THEIR PATIENT SPAT OUT FROM THEIR MOUTH THE OE-A63 STERILE DISTAL END CAP. THE PHYSICIAN ATTACHED THE OE-A63 TO THE ED34-I10T2 DUODENOSCOPE PRIOR TO THE PROCEDURE START. HOWEVER, THE PROCEDURE WAS ABLE TO BE PERFORMED TO COMPLETION, WITHOUT ANY ISSUES DURING THE CASE. THERE WAS NO REPORTED HARM TO THE PATIENT AND THE PATIENT WAS NOT RECALLED FOR FURTHER SCREENING. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18861771 ↗
• InjuryAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 08-AUG-2023 THAT OCCURRED IN THE ENDOSCOPY SUITE DURING USE IN CANADA ON (B)(6) 2023. THE CUSTOMER REPORTED THAT A STERILE SINGLE USE DISTAL END CAP(DEC), MODEL OE-A63, LOT NUMBER 0031102, CAME OFF DURING INTUBATION AND THEY SWITCHED TO A GASTROSCOPE. THE DEC WAS LODGED BETWEEN THE VOCAL CORDS. HENCE, BX[BIOPSY] FORCEPS AND A BASKET WERE USED TO REMOVE AND RETRIEVE THE CAP. THE MANUFACTURER AND MODEL OF THE FORCEPS AND BASKET WERE NOT PROVIDED. THE STERILE SINGLE USE DISTAL END CAP(DEC) WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT STATUS IN UNKNOWN AT THIS POINT. THE STERILE SINGLE USE DISTAL CAP WAS USED WITH PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2, SERIAL NUMBER (B)(6). THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17608893 ↗