Single Use Electrosurgical Knife KD-611LRecalls & reported problems

Summary

The FDA's MAUDE database contains 357 adverse event reports that list this exact device (DI 04953170225963), received between Jun 25, 2018 and Aug 7, 2025 — classified as 1 death, 160 injuries, 196 malfunctions.

The most frequently reported specific device problem is “Break” (229 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 357 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC SEPTOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. IT WAS OBSERVED THAT THE OPERATOR WAS USING THE DEVICE WITH A LOT OF ENERGY IN THE CUT MODE. THE OPERATOR LOOKED FOR THE TIP THAT FELL OFF INSIDE THE PATIENT BUT COULD NOT FIND IT. THE FALLEN TIP WAS NOT RETRIEVED. THE USERS REPORTEDLY WERE NOT WORRIED ABOUT IT TOO MUCH. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND COMPLETED SUCCESSFULLY WITH A DIFFERENT KNIFE. THE PATIENT WAS STABLE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22742969 ↗
• InjuryAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC SEPTOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. IT WAS OBSERVED THAT THE OPERATOR WAS USING THE DEVICE WITH A LOT OF ENERGY IN THE CUT MODE. THE OPERATOR LOOKED FOR THE TIP THAT FELL OFF INSIDE THE PATIENT BUT COULD NOT FIND IT. THE FALLEN TIP WAS NOT RETRIEVED. THE USERS REPORTEDLY WERE NOT WORRIED ABOUT IT TOO MUCH. THE PROCEDURE WAS PROLONGED BY LESS THAN 30 MINUTES AND COMPLETED SUCCESSFULLY WITH A DIFFERENT KNIFE. THE PATIENT WAS STABLE AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22742955 ↗
• InjuryDec 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20909724 ↗
• InjuryDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CERAMIC TIP OF THE KNIFE FELL OFF AND INTO THE PATIENT¿S STOMACH DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE PROCEDURE WAS DELAYED FOR 15 MINUTES TO RETRIEVE THE DEVICE. ALTHOUGH REQUESTED, IT IS UNKNOWN HOW THE DEVICE WAS RETRIEVED, AND IF ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859655 ↗
• InjuryNov 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE (ESD), THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. IT WAS IMMEDIATELY RETRIEVED WITH THE AID OF GRASPING FORCEPS AND AN ENDOSCOPE. THE PROCEDURE WAS PROLONGED BY 5-6 MINUTES REQUIRED FOR RETRIEVAL OF THE TIP FALLEN IN THE STOMACH. NO ADDITIONAL SEDATION WAS NEEDED. THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE, AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EFFECTS AND NO COMPLICATIONS REPORTED. NO DAMAGE TO THE PATIENT AND NO RELEVANT MEDICAL CONDITIONS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616993 ↗
• MalfunctionOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE SUBJECT DEVICE FELL OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544939 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY OF A NOVEL TRACTION METHOD: OUTSIDE-LESION CLIP-THREAD METHOD FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION OF LESIONS OF THE GREATER CURVATURE OF THE UPPER/MIDDLE STOMACH (WITH VIDEO)." ABSTRACT: BACKGROUND - GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR LESIONS LOCATED ON THE GREATER CURVATURE OF THE UPPER AND MIDDLE (U/M) THIRD OF THE STOMACH REMAINS CHALLENGING, EVEN FOR EXPERIENCED ENDOSCOPISTS. ACCORDINGLY, WE HAVE DEVELOPED A NOVEL TRACTION TECHNIQUE, TERMED THE OUTSIDE-LESION CLIP-THREAD METHOD (O-CTM). IN THIS METHOD, A CLIP THREAD IS ATTACHED TO THE HEALTHY MUCOSA OUTSIDE THE CIRCUMFERENTIAL INCISION LINE, AND TRACTION IS APPLIED TO BRING THE SCOPE AND LESION INTO PROXIMITY FOR ESD. HERE, WE ASSESSED THE EFFICACY OF ESD USING THE O-CTM COMPARED TO ESD WITHOUT THE O-CTM. METHODS: WE RETROSPECTIVELY REVIEWED DATA FROM (B)(4) CONSECUTIVE PATIENTS WHO UNDERWENT GASTRIC ESD FOR (B)(4) LESIONS LOCATED ON THE GREATER CURVATURE OF THE U/M THIRD OF THE STOMACH BETWEEN (B)(6) 2015 AND (B)(6) 2024. THE PRIMARY OUTCOME WAS THE OPERATION TIME, AND SECONDARY OUTCOMES WERE RESECTION SPEED, EN BLOC RESECTION, R0 RESECTION AND

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20495806 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ORIGINAL ARTICLE ENDOSCOPIC FULL-THICKNESS RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER PROSPECTIVE STUDY." EARLY GASTRIC CANCER ENDOSCOPIC RESECTION (ER) IS PROMINENT IN JAPAN. HOWEVER, EVIDENCE REGARDING ER OF GASTRIC SUBMUCOSAL TUMORS (SMT) IS LIMITED. THIS PROSPECTIVE MULTICENTER PHASE II STUDY INVESTIGATED THE EFFICACY AND SAFETY OF ENDOSCOPIC FULL-THICKNESS RESECTION (EFTRF)O R GASTRIC SMT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS/INTERVENTIONS. EVENT1: DELAYED PERFORATION (1 CASE- CLAVIEN¿ DINDO GRADE IIIA). THIS WAS SWIFTLY MANAGED WITH ENDOSCOPIC INTERVENTION. EVENT2: INTRAPROCEDURAL HEMORRHAGE (NUMBER OF OCCURRENCES NOT STATED). THESE WERE MANAGED VIA ENDOSCOPIC FORCEPS COAGULATION; NO CASE REQUIRED BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation

  MAUDE report 20408209 ↗
• InjuryOct 7, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THAT DURING UPPER GASTROINTESTINAL ELECTROSTATIC DISCHARGE (ESD) THE TIP OF THE ELECTROSURGICAL KNIFE WAS BROKEN OFF WHEN ELECTRICITY WAS APPLIED. THE DOCTOR DECIDED NOT TO RETRIEVE THE BROKEN PIECE, BUT TO REPLACE IT WITH ANOTHER SIMILAR DEVICE AND COMPLETE THE PROCEDURE WITHOUT AFFECTING THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382205 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE DERIVATION AND EXTERNAL VALIDATION OF A FIBROSIS RISK MODEL FOR COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY AIMED TO DERIVE AND VALIDATE A PREDICTION MODEL TO DETERMINE THE PREOPERATIVE DEGREE OF SUBMUCOSAL FIBROSIS IN COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 309 PATIENTS (AGE: 68 ± 10.9 YEARS) UNDERWENT COLORECTAL ESD. NO FIBROSIS (F0), F1 FIBROSIS, AND F2 FIBROSIS WERE REPORTED IN 196 (63.4%), 70 (22.6%), AND 43 (13.9%) CASES, RESPECTIVELY. COMPLICATIONS WERE EXPERIENCED IN 20 (6.4%) RESECTIONS, 10 (3.2%) BEING PERFORATIONS AND 10 (3.2%) SIGNIFICANT BLEEDING. AFTER DISSECTION, HEMOSTASIS WAS PERFORMED WITH A COAGRASPER WHENEVER NECESSARY, AND DEFECTS WERE CLOSED WITH THROUGH-THE-SCOPE CLIPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION/10 PATIENTS. SIGNIFICANT BLEEDING/10 PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20351570 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE WAS DETACHED. THE ISSUE OCCURRED DURING THE THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348135 ↗
• InjurySep 30, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THE TIME TO COLLECT THE SUBJECT DEVICE WAS 10 MINUTES AND THE SUBJECT DEVICE FELL IN THE COLON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338643 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE'S INSULATING TIP BROKE WHEN IT WAS REMOVED FROM THE FORCEPS PORT AND FELL INTO THE SUCTION BOTTLE WHEN TRYING TO REPLACE THE DEVICE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A REPLACEMENT WITH A NEW ONE OF THE SAME PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262985 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC GASTRIC PROCEDURE (ESD), THE BALL TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S STOMACH. THE DOCTOR NOTICED THE MISSING TIP AND HAD FALLEN OFF AND THE DOC DECIDED NOT TO COLLECT THE TIP BALL BUT TO WAIT FOR IT TO BE NATURALLY EXPELLED. THE PROCEDURE WAS COMPLETED ON A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213425 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED THAT INSULATION TIP WAS CHIPPED. THE ISSUE OCCURRED DURING THERAPEUTIC ELECTROSTATIC DISCHARGE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152606 ↗
• InjurySep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF INSIDE THE PATIENT'S BODY DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). IT WAS UNCLEAR WHERE THE TIP FELL OFF, BUT IT HAS BEEN RETRIEVED. THE METHOD OF RETRIEVAL WAS UNKNOWN. THE DOCTOR REPLACED IT WITH A SIMILAR DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148614 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE, THE SINGLE USE ELECTROSURGICAL KNIFE WAS REMOVED FROM THE SCOPE AND THE BALL TIP FELL OFF. THE INSULTATION TIP FELL OFF OUTSIDE OF THE BODY WHEN WIPING OFF THE BURNT PARTS WITH A CLOTH. IT WAS NOTED THAT IT FELL OFF BEFORE MUCH FORCE WAS APPLIED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT IMPACT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088986 ↗
• InjuryAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INSIDE THE PATIENT'S BODY. IT WAS IMMEDIATELY RETRIEVED AND REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077101 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO DEVICE MALFUNCTION DURING ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE. ALSO, AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ADVERSE EVENTS.

  Patient problems: Stenosis of the esophagus

  MAUDE report 20071880 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE AUTHOR REPORTED THAT FURTHER EVENT DETAILS ARE UNKNOWN.

  Patient problems: Bacterial Infection; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count

  MAUDE report 20065571 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING CASE STUDY TITLED "A CASE OF DELAYED PERFORATION AFTER GASTRIC ESD SUCCESSFULLY TREATED CONSERVATIVELY WITH OTSC" REGARDING AN 80 YEAR OLD MALE WITH GASTRIC CANCER WITH HISTORY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AT THE AGES OF 64, 75, AND 78 (4 LESIONS IN TOTAL). THE PATIENT WAS SUFFERING FROM ANGINA PECTORIS, CHRONIC KIDNEY DISEASE (NEPHROSCLEROSIS, G4AL), AND DIABETES MELLITUS (TAKING CLOPIDOGREL 75 MG, ETC.). ESD WAS PERFORMED ON A 15-MM LARGE 0-ILA LESION ON THE POSTERIOR WALL OF THE MIDLINE OF THE GASTRIC BODY. AT THE TIME OF TREATMENT, 2 0-ILA LESIONS OF 5 MM IN SIZE WERE ALSO FOUND ON THE POSTERIOR WALL OF THE GASTRIC HORN, RESULTING IN RESECTION OF 3 LESIONS (2 SPECIMENS) IN TOTAL. THE IT KNIFE2 WAS USED, AND THERE WAS NO INTRAOPERATIVE BLEEDING THAT WAS DIFFICULT TO TREAT, AND COAGULATION AND HEMOSTASIS WERE PERFORMED AS NEEDED USING COAGRASPER. THE TREATMENT TIME/RESECTION SPECIMEN DIAMETER FOR THE POSTERIOR WALL LESIONS OF THE MIDDLE GASTRIC BODY AND GASTRIC HORN WAS 37 MIN/37 MM AND 34 MIN/28 MM, RESPECTIVELY, AND THE TREATMENT WAS COMPLETED WITHOUT ANY PROBLEMS. AFTER THE DISSECTION WAS COMPLETED, THERE WAS AN AREA OF OOZING FROM T

  Patient problems: Abdominal Pain; Fever; Internal Organ Perforation; Pneumoperitoneum

  MAUDE report 20053966 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE TIP OF THE ELECTROSURGICAL KNIFE WAS SUDDENLY MISSED MIDWAY THROUGH THE PROCEDURE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION AND THE SAME PRODUCT WAS USED FOR PROCEDURE COMPLETION. THE FALLEN TIP WAS NEVER FOUND AND WAS NOT RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049533 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EFFICACY AND SAFETY OF MC-003 SOLUTION FOR ENDOSCOPIC MUCOSAL OR SUBMUCOSAL RESECTION: A PROSPECTIVE, MULTICENTER, RANDOMIZED, TRIPLE-BLINDED, PARALLEL-GROUP, PHASE III STUDY." BACKGROUND AND AIMS: THE SAFETY AND EFFICACY OF SOLUTIONS FOR SUBMUCOSAL INJECTION ARE CRITICAL FOR ENDOSCOPIC RESECTION OF GASTRIC ADENOMAS OR EARLY GASTRIC CANCERS. ALTHOUGH SEVERAL INJECTABLE SOLUTIONS HAVE BEEN INTRODUCED FOR ENDOSCOPIC RESECTION, THEY HAVE SOME LIMITATIONS. WE AIMED TO COMPARE THE EFFICACY OF THE NEW SODIUM ALGINATE¿BASED SOLUTION MC-003 WITH THAT OF NORMAL SALINE (NS; 0.9% SODIUM CHLORIDE). METHODS: IN THIS RANDOMIZED, TRIPLE-BLIND STUDY, 70 PATIENTS WERE INITIALLY ENROLLED FOR EMR OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE MAIN OUTCOMES INCLUDED THE NEED FOR ADDITIONAL INJECTIONS, COMPLETION OF EN BLOC RESECTION, AND OCCURRENCE OF ADVERSE EVENTS. RESULTS: EACH GROUP ULTIMATELY INCLUDED 34 PATIENTS. COMPLETE EN BLOC RESECTIONS WERE ACHIEVED IN ALL PATIENTS (P Z 1.000). THE MC-003 GROUP HAD MORE PERI-NEOPLASM TISSUE FIBROSIS (P Z .056) AND NEEDED FEWER ADDITIONAL INJECTIONS FOR LESIONS >15 MM (P Z .037), LOCATED IN THE DISTAL PORTION

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 20042245 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE USE ELECTROSURGICAL KNIFE INSULATION TIP FELL INTO THE PATIENTS BODY AND WAS NOT RETRIEVED. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036709 ↗
• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INSIDE THE PATIENT'S BODY. THE TIP WAS NOT RECOVERED BUT THE DEVICE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE WAS COMPLETED. AT THE DISCRETION OF THE ATTENDING PHYSICIAN, IT WAS DETERMINED THAT THE UNRECOVERED CHIPS WERE EXPECTED TO BE NATURALLY EXCRETED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025795 ↗