Single Use Electrosurgical Knife KD-625 KD-625LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170407826), received between Jun 10, 2022 and Nov 13, 2024 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "SAFETY OF EDOXABAN FOR DELAYED BLEEDING IN GASTROINTESTINAL ENDOSCOPIC PROCEDURES WITH A HIGH RISK OF BLEEDING." THIS STUDY INVESTIGATED THE SAFETY OF GASTROINTESTINAL ENDOSCOPIC PROCEDURES IN PATIENTS TAKING EDOXABAN, A DIRECT ORAL ANTICOAGULANT, FOCUSING ON THE INCIDENCE OF DELAYED BLEEDING DURING THE PERIOPERATIVE PERIOD. CONDUCTED FROM (B)(6) 2018 TO (B)(6) 2021, THE SINGLE-CENTER, OPEN-LABEL STUDY INCLUDED (B)(4) PATIENTS ON EDOXABAN UNDERGOING HIGH-RISK ENDOSCOPY. THE PRIMARY OUTCOME, SEVERE DELAYED BLEEDING (CTCAE GRADES III¿V), OCCURRED IN (B)(4) OF PATIENTS, ALL REQUIRING ENDOSCOPIC HEMOSTASIS. NO CASES OF MILD OR MODERATE DELAYED BLEEDING (CTCAE GRADES I-II) OR THROMBOEMBOLIC EVENTS WERE OBSERVED. SECONDARY OUTCOMES INCLUDED COMPLICATIONS LIKE CHOLANGITIS AND ASPIRATION PNEUMONIA, WHICH WERE CONSERVATIVELY TREATED, AND THE MEDIAN HOSPITAL STAY WAS 8 DAYS. PATIENTS WITH DELAYED BLEEDING HAD HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION AND LONGER HOSPITAL STAYS. THE STUDY FOUND THAT THE INCIDENCE OF DELAYED BLEEDING IN THESE PATIENTS WAS ACCEPTABLE, WITH HIGHER SYSTOLIC BLOOD PRESSURE AT ADMISSION ASSOCIATED WITH INCREASED RI

  Patient problems: Aspiration Pneumonitis; Cholangitis; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20678089 ↗
• MalfunctionMar 18, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF INTO THE PATIENT'S BODY. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE AFTER THE KNIFE WAS ENERGIZED ONCE. THE PART WAS COLLECTED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922895 ↗
• MalfunctionFeb 13, 2024Break; Break

  THE CUSTOMER REPORTED TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE. THE ISSUE OCCURRED AFTER ABOUT AN HOUR OF USE DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. NO PARTS DROPPED INTO THE PATIENT'S BODY. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693644 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18664468 ↗
• InjuryFeb 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE TIP PART BROKE AND FELL INTO THE BODY WHILE PEELING WITH THE FORCEPS. THE FALLEN PIECES HAVE BEEN COLLECTED. THE ISSUE OCCURRED DURING AN ENDOSCOPIC MUCOSAL RESECTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639076 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE S-O CLIP FOR DUODENAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A PROPENSITY SCORE-MATCHED STUDY." THIS RETROSPECTIVE STUDY EVALUATED THE EFFICACY AND SAFETY OF DUODENAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING AN S-O CLIP FOR SNADETS. THE RETROSPECTIVE STUDY WAS PATIENTS WHO UNDERWENT ESD FOR SNADETS BETWEEN JANUARY 2011 AND DECEMBER 2021. PROPENSITY SCORE MATCHING ANALYSIS WAS USED TO COMPARE PATIENTS WHO UNDERWENT DUODENAL ESD WITH THE S-O CLIP (S-O GROUP) AND THOSE WHO UNDERWENT CONVENTIONAL ESD (CONTROL GROUP). SIXTY PATIENTS WITH SNADETS WHO WERE TREATED WITH ESD WERE ENROLLED. AFTER PROPENSITY SCORE MATCHING, 16 PAIRS WERE CREATED: 43 AND 17 IN THE S-O AND CONTROL GROUPS, RESPECTIVELY. ALL ESD PROCEDURES WERE PERFORMED USING A SINGLE-CHANNEL ENDOSCOPE (GIF-H260J) WITH A TRANSPARENT HOOD (D-201-11804) AND HOOK KNIFE (KD-625LR). S-O GROUP: 43 PATIENTS DELAYED BLEEDING: 2 PATIENTS CONTROL GROUP: 17 PATIENTS INTRAOPERATIVE PERFORATION: 4 PATIENTS DELAYED PERFORATION: 1 PATIENT IN CASE OF DELAYED COMPLICATIONS, COMPUTED TOMOGRAPHY AND BLOOD TESTS WERE PERFORMED. DELAYED BLEEDING TREATED WITH ENDOSCOPIC HEMOSTASIS AFT

  Patient problems: Abscess; Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18636432 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM OUTCOMES AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL EPITHELIAL NEOPLASMS IN PATIENTS WITH SEVERE COMORBIDITIES". THE PURPOSE OF THE STUDY WAS TO EXAMINE THESE LONG-TERM OUTCOMES AND COMPARED THEM WITH THOSE IN PATIENTS WITH NON-SEVERE COMORBIDITIES. 231 PATIENTS WITH COLORECTAL EPITHELIAL NEOPLASMS (CENS) UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN APRIL 2005 AND MARCH 2023. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE FOR ALL 5 PATIENT IDENTIFIERS: EVENT 1: DELAYED BLEEDING (N=4). EVENT 2: PERFORATION (N=11). THIS LITERATURE ARTICLE REQUIRES 5 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : KD-655L. (B)(6) : KD-612L. (B)(6) : KD-625LR. (B)(6) : PCF-Q260AZI. (B)(6) : PCF-H290ZI. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) , MODEL KD-625LR.

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18434802 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC DILATION FOR STENOSIS AFTER ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION: KNACK AND PITFALLS".WHEN A POST-RESECTION ULCER IS EXPECTED TO INVOLVE MORE THAN THREE-FOURTHS OF THE ESOPHAGEAL CIRCUMFERENCE, IT IS ADVISABLE TO CONSIDER PREVENTIVE MEASURES AGAINST STENOSIS, SUCH AS SUBMUCOSAL TRIAMCINOLONE INJECTION, AS SUCH LESIONS ARE ASSOCIATED WITH A HIGH RISK OF STENOSIS FOLLOWING ENDOSCOPIC RESECTION. IN THE CASE OF STRICTURE DEVELOPMENT, ENDOSCOPIC BALLOON DILATION (EBD) IS PERFORMED. TO PREVENT PERFORATION DURING EBD, IT IS RECOMMENDED TO USE A 12-15 MM BALLOON AND GRADUALLY INCREASE THE PRESSURE TO 8 ATM OVER 4 MIN. FOR SEVERE STENOSIS, A 10-12MM BALLOON IS USED. IN THE EVENT OF A PERFORATION DURING EBD, FASTING AND ADMINISTRATING ANTIBIOTICS ARE NECESSSARY. IF CONSERVATIVE TREATMENT FAILS TO SHOW ANY IMPROVEMENT, SURGICAL DRAINAGE SHOULD BE CONSIDERED.TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTSPOSTOPERATIVE STENOSIS- 3 PATIENTS,PERFORATION- 1 PATIENT.THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : KD-625LR.(B)(6) : GIF-H290T.THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALF

  Patient problems: Perforation; Stenosis

  MAUDE report 18379429 ↗
• MalfunctionAug 28, 2023Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE COULD NOT BE EXTENDED IN THE INVERSION POSITION. THE ISSUE OCCURRED WITH SIX KNIVES DURING THE PROCEDURE. THREE OF THE KNIVES BROKE OFF DIRECTLY OUTSIDE OF THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630614 ↗
• MalfunctionAug 28, 2023Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE COULD NOT BE EXTENDED IN THE INVERSION POSITION. THE ISSUE OCCURRED WITH SIX KNIVES DURING THE PROCEDURE. THREE OF THE KNIVES BROKE OFF DIRECTLY OUTSIDE OF THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630606 ↗
• MalfunctionAug 28, 2023Break; Break

  THE CUSTOMER REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE COULD NOT BE EXTENDED IN THE INVERSION POSITION. THE ISSUE OCCURRED WITH SIX KNIVES DURING THE PROCEDURE. THREE OF THE KNIVES BROKE OFF DIRECTLY OUTSIDE OF THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630605 ↗
• InjuryJun 22, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE TIP OF THIS SINGLE USE ELECTROSURGICAL KNIFE FELL OFF INSIDE THE PATIENT'S BODY. THE FALLEN PART WAS RECOVERED, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184846 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "EFFECT OF DIFFERENT DEVICES ON ESOPHAGEAL ESD ON ESOPHAGEAL STRICTURE"     LITERATURE SUMMARY. [BACKGROUND / PURPOSE] EXTENSIVE RESECTION IS THE MAIN CAUSE OF STENOSIS IN ESOPHAGEAL ESD, AND ADMINISTRATION OF STEROIDS IS USEFUL FOR ITS PREVENTION. HOWEVER, THE CURRENT SITUATION IS THAT POSTOPERATIVE STENOSIS CANNOT BE COMPLETELY PREVENTED EVEN IF STENOSIS PREVENTION MEASURES ARE TAKEN. WHEN WE EXAMINED ESD PROCEDURES THAT DID NOT CAUSE STENOSIS, WE SUSPECTED THAT THERE MIGHT BE DIFFERENCES IN THE STENOSIS RATE DEPENDING ON THE DEVICE. THIS TIME, WE WILL CLARIFY THE EFFECT OF DIFFERENT DEVICES ON POST-ESOPHAGEAL ESD STENOSIS USING A SYSTEMATIC REVIEW (STUDY 1: SL), AND PATHOLOGICALLY EVALUATE THE DIFFERENCE IN CASES WITH ADDITIONAL RESECTION AFTER ESOPHAGEAL ESD (STUDV2): S2). [METHOD] SEARCH FOR ARTICLES UP TO 2020 USING S1: PUBMED, COCHRANE LIBRARY, AND ICHUSHI. THE CRITERIA FOR ADOPTION ARE ESD FOR SQUAMOUS CELL CARCINOMA OF THE ESOPHAGUS AND PREESOPHAGEAL CARCINOMA LESIONS, PERI-MATERIAL 3/4 OR MORE LAPS, AND STENOSIS. EXCLUSION CRITERIA WERE CE AND AE, WHICH ARE PRONE TO STENOSIS, STENOSIS PREVENTIVE TREATMENT, AND PREOPERATIVE AND PO

  Patient problems: Stenosis of the esophagus

  MAUDE report 14657330 ↗