Radial Jaw 4 M00513410Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729745679), received between Jul 11, 2017 and Sep 14, 2026 — classified as 11 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 30, 2026Class IIOpen, Classified

   Potential for breach in sterile barrier of device packaging.

   Z-2838-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755035 ↗
• InjuryMar 4, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 WAS USED IN THE STOMACH DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, AT THE SECOND BIOPSY ATTEMPT, THE METAL JAWS OF THE BIOPSY FORCEPS DISENGAGED FROM THE CATHETER AND BROKE OFF INTO THE PATIENT. A BRONCHOSCOPY WAS PERFORMED TO ENSURE NO PIECES WERE ASPIRATED INTO THE AIRWAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505427 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component

  DURING THE EGD [ESOPHAGOGASTRODUODENOSCOPY], OPENED AN UNUSED STANDARD BIOPSY FORCEP, GAVE IT TO THE PHYSICIAN WHO THREAD THE FORCEP INTO THE SCOPE AND WHEN THE FORCEP WAS OPENED, A TINY PIECE OF (WHAT LOOKED LIKE) METAL CAME OUT OF THE END OF THE FORCEP/ GRASPER PART. THE PHYSICIAN WAS ABLE TO RETRIEVE THE WHOLE PIECE RIGHT AWAY AND NO DAMAGE TO THE PATIENT WAS DONE FROM IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050929 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UNKNOWN NUMBER OF RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WERE USED DURING GASTRIC BIOPSY PROCEDURES PERFORMED OVER THE PAST 6 MONTHS TO ONE YEAR. COMPLICATIONS VARYING FROM MILD BLEEDING WITH MELAENA TO SEVERE BLEEDING WITH HEMOGLOBIN DROPS AND HOSPITALIZATION OCCURRED 24 TO 48 HOURS POST PROCEDURE. IN CERTAIN CASES, WHERE THE BLEEDING WAS OBSERVED IMMEDIATELY, CLIPS WERE PLACED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20360412 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SC BIOPSY FORCEPS WAS USED IN THE UPPER GI TRACT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT EXPERIENCED DELAYED BLEEDING IN THE UPPER GI AND WENT TO THE EMERGENCY ROOM (ER). A CLIP WAS PLACED AT THE SITE OF THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19772713 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, BLEEDING WAS NOTICED AFTER A GASTRIC BIOPSY, HOWEVER THE PHYSICIAN FELT IT WAS NOT SIGNIFICANT ENOUGH TO PLACE A CLIP. TWO DAYS AFTER THE PROCEDURE, THE PATIENT CALLED TO REPORT THEY WERE EXPERIENCING BLOOD IN THEIR STOOL. THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM AND THERE THEY RECEIVED 2 LITERS OF BLOOD. THE PHYSICIAN THOUGHT THAT THE BITE TAKEN BY THE BIOPSY FORCEPS CAUSED THE BLACK STOOL. THE PATIENT FULLY RECOVERED AND WAS SENT HOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19142240 ↗
• MalfunctionSep 7, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 - SC - BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT A METAL PIECE IS STICKING OUT THE SIDE OF THE FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE DEVICE WAS PROVIDED BY THE CUSTOMER SHOWING THE DEVICE OUTSIDE THE PATIENT WITH AN UNKNOWN PIECE STICKING OUT OF THE SIDE OF THE FORCEPS JAWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17698692 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND A HEMATOMA. THE DOCTOR DID NOT BELIEVE THAT A CLIP WAS NECESSARY TO STOP THE BLEEDING. HOWEVER, THE PATIENT RETURNED TO THE EMERGENCY ROOM 2 TO 3 DAYS LATER WITH A DELAYED BLEED. ANOTHER DOCTOR USED COAGULATION AND CLIPS TO TREAT THE PROBLEM. NO OTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THE PATIENT FULLY RECOVERED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16604470 ↗
• MalfunctionDec 16, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW BIOPSY FORCEPS WAS TO BE USED IN AN UNKNOWN PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, A DEAD BUG WAS FOUND INSIDE THE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999290 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW4 BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2022, THE PATIENT WAS SENT FOR A REPEAT COLONOSCOPY WHERE SEVERE TRAUMA AT BIOPSY SITES WERE NOTED THAT RESULTED IN DELAYED BLEEDING. CLIPS WERE PLACED TO CONTROL THE BLEEDING. THE PATIENT FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 15102612 ↗
• MalfunctionApr 21, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKAGING A RADIAL JAW 4 STANDARD CAPACITY, A HAIR WAS FOUND WITHIN THE STERILE PACKAGE OF THE FORCEPS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168092 ↗
• MalfunctionJan 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 PEDIATRIC BIOPSY FORCEPS WAS USED DURING A GASTROSCOPY AND COLONOSCOPY PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS WERE INSERTED INTO THE WORKING CHANNEL OF THE SCOPE. ONCE THE FORCEPS WERE EXPOSED AT THE DISTAL TIP OF THE SCOPE, THERE WAS VISIBLE FOREIGN MATTER ON THE SCREEN THAT ATTACHED TO THE END OF FORCEPS. THE FORCEPS WERE REMOVED FROM THE PATIENT BUT THE FOREIGN MATTER COULD NOT BE RETRIEVED. FOLLOWING THE REMOVAL OF THE GASTROSCOPE FROM THE PATIENT, A CLEANING BRUSH WAS INSERTED DOWN THE BIOPSY CHANNEL TO EXPOSE ANY FOREIGN MATTER IN THE CLEANING ROOM. A SMALL AMOUNT OF FOREIGN MATTER WAS FOUND VISIBLE. THE CLEANING BRUSH TIP WAS REMOVED AND PLACED IN FORMALIN TO BE SENT TO PATHOLOGY. THE PATHOLOGY RESULTS COULD NOT CONCLUSIVELY DETERMINE IF THE MATERIAL WAS HUMAN TISSUE OR NOT. THE PATIENT ALSO HAD A GASTRIC POLYP. IT IS CONSIDERED POSSIBLE THAT THE POLYP TISSUE MAY HAVE BEEN DISLODGED AS THE GASTROSCOPE WAS ADVANCED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11141503 ↗
• InjuryDec 18, 2020Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WITH NEEDLE WAS USED IN A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE FORCEPS DID NOT CLEANLY TAKE A BITE BUT WAS TEARING EXCESS TISSUE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THE PATIENT WAS DISCHARGED. ON THE SAME DAY, THE PATIENT EXPERIENCE BLEEDING AND RETURNED TO THE HOSPITAL. THE PATIENT WENT TO THE ACCIDENT AND EMERGENCY (A&E) DEPARTMENT BUT WAS NOT ADMITTED TO THE WARD. ON THE NEXT DAY, THE PATIENT EXPERIENCED A SMALL AMOUNT OF BLEEDING AND RETURNED TO A&E. REPORTEDLY, NO TREATMENT FOR THE BLEEDING WAS PERFORMED AT A&E.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Damage

  MAUDE report 11041352 ↗
• MalfunctionMay 2, 2019Entrapment of Device; Difficult to Open or Close; Device Contamination with Chemical or Other Material; Material Integrity Problem; Entrapment of Device; Difficult to Open or Close; Device Contamination with Chemical or Other Material; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED IN THE COLON DURING A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FORCEPS GOT STUCK INSIDE THE SCOPE AND THE PROCEDURE WAS DISCONTINUED. ONCE THE FORCEPS WAS REMOVED FROM THE SCOPE, ONE SIDE OF THE JAWS WAS FOUND TO BE OPENED AND A BLACK VINYL WAS NOTED STUCK ON THE JAW'S TEETH. IT WAS SUSPECTED THAT THE SCOPE WAS DAMAGED AND WAS SENT FOR REPAIR. THE SCOPE WAS INSPECTED AND IT WAS CONFIRMED THAT THE BLACK VINYL LIKE OBJECT WAS NOT FROM THE INTERNAL LUMEN OF SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575503 ↗
• MalfunctionOct 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A FOREIGN BODY WAS FOUND INSIDE THE CUP WHEN THEY OPENED THE BIOPSY FORCEPS. THE FOREIGN BODY DROPPED INTO THE PATIENT AND THEY WERE UNABLE TO FIND IT. THEY USED ANOTHER OF THE SAME FORCEPS TO COMPLETE THE CASE. ADDITIONALLY, IT WAS REPORTED THAT THE FOREIGN BODY WAS LIGHT YELLOW ORANGE THAT LOOKED LIKE THE CATHETER OF THE FORCEPS. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7992703 ↗
• MalfunctionSep 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS TO BE USED FOR A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A STRAND OF HAIR WAS NOTICED INSIDE THE PACKAGING. THE PACKAGE WAS NOT OPENED AND ANOTHER RADIAL JAW WAS USED FOR THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THIS HAPPENED BEFORE THE PATIENT AND PHYSICIAN WERE IN THE ROOM.

  Patient problems: No Patient Involvement

  MAUDE report 7902116 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 STANDARD CAPACITY WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE STOMACH OR COLON DURING A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, BLEEDING WAS NOTED AFTER THE PROCEDURE. THE PATIENT WAS RE-HOSPITALIZED AND THE BLEEDING WAS TREATED WITH HEMOSTATIC CLIPPING AND HEMOSPRAY. REPORTEDLY, THE PATIENT WAS ¿WITHOUT REAL RISK FACTORS¿ FOR HEMORRHAGIC EVENTS.

  Patient problems: Blood Loss

  MAUDE report 7639803 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 STANDARD CAPACITY WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE STOMACH OR COLON DURING A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, BLEEDING WAS NOTED AFTER THE PROCEDURE. THE PATIENT WAS RE-HOSPITALIZED AND THE BLEEDING WAS TREATED WITH HEMOSTATIC CLIPPING AND HEMOSPRAY. REPORTEDLY, THE PATIENT WAS ¿WITHOUT REAL RISK FACTORS¿ FOR HEMORRHAGIC EVENTS.

  Patient problems: Blood Loss

  MAUDE report 7639473 ↗
• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 STANDARD CAPACITY WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE STOMACH OR COLON DURING A BIOPSY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, BLEEDING WAS NOTED AFTER THE PROCEDURE. THE PATIENT WAS RE-HOSPITALIZED AND UNDERWENT TRANSFUSION. REPORTEDLY, THE PATIENT WAS ¿WITHOUT REAL RISK FACTORS¿ FOR HEMORRHAGIC EVENTS.

  Patient problems: Blood Loss

  MAUDE report 7639424 ↗
• MalfunctionJun 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 STANDARD CAPACITY BIOPSY FORCEPS WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE FORCEPS WAS PASSED THROUGH THE SCOPE AND THE JAWS WAS OPENED, A FOREIGN BODY WAS FOUND INSIDE THE CUP. THE FORCEPS WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿FINE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567006 ↗
• MalfunctionMay 15, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW¿ 4 BIOPSY FORCEPS WAS USED IN THE COLON DURING A BIOPSY PROCEDURE PERFORMED ON UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, ONCE THE FORCEPS PASSED THROUGH THE SCOPE THE PHYSICIAN NOTED THAT A PIECE OF TISSUE WAS SEEN EXITING THE SCOPE ALONG WITH THE FORCEPS. THE FORCEPS WAS IMMEDIATELY REMOVED. UPON INSPECTION, A PIECE OF TISSUE WAS SEEN INSIDE THE FORCEPS ATTACHED TO THE NEEDLE. IT IS UNKNOWN IF THE FORCEPS WERE INSPECTED PRIOR TO USE, AS INSTRUCTED IN THE DIRECTIONS FOR USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿GOOD¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517357 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW¿ 4 STANDARD CAPACITY WITH NEEDLE BIOPSY FORCEPS WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, WHEN THE PATIENT WENT HOME, THE PATIENT EXPERIENCE MELENA AND DIZZINESS. THE PATIENT WAS ADVISED TO GO TO THE ER. A HEMOGLOBIN (HBG) TEST WAS PERFORMED, DETERMINING IT HAD DROPPED. ANOTHER EGD WAS PERFORMED AND A CLIP WAS PLACED ON A SMALL VESSEL TO STOP THE BLEEDING AT THE GE JUNCTION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿STABLE¿. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS NO MALFUNCTION OR DAMAGE NOTED ON THE DEVICE DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7051885 ↗
• MalfunctionAug 18, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY WITH NEEDLE BIOPSY FORCEPS WAS GOING TO BE USED FOR A COLONOSCOPY PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A HAIR WAS NOTICED INSIDE THE STERILE PACKAGING. ADDITIONALLY, THE DEVICE WAS UNOPENED AND NO DAMAGE WAS NOTED ON THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE ¿FINE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803673 ↗
• MalfunctionJul 11, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 STANDARD CAPACITY BIOPSY FORCEPS WAS TO BE USED IN A BIOPSY PROCEDURE IN THE OESOPHAGUS PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTED THAT A BIT OF METAL HAD COME OFF AT THE END OF THE JAWS WHILE INSIDE THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; FOREIGN MATTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6703918 ↗