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n.a. 37370DLRecalls & reported problems

Karl Storz GmbH & Co. KG · Coagulating and Dissecting Electrode · Class 2

Adverse event reports
13
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04048551155653), received between Oct 18, 2019 and Jul 1, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break5
  • Material Separation5
  • Material Fragmentation2
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • No Consequences Or Impact To Patient2
  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1
  • Insufficient Information1
  • Patient Problem/Medical Problem1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 1, 2026Break

    IT WAS REPORTED THAT THE HOOK BROKE DURING THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25680143 ↗
  • MalfunctionJul 1, 2025Break; Break

    ACCORDING TO THE INFORMATION RECEIVED, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE ELECTROCAUTERY HOOK BROKE WITHIN THE SURGICAL SITE. THE FRAGMENT WAS FULLY RETRIEVED WITHOUT ANY COMPLICATIONS. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22378804 ↗
  • MalfunctionApr 22, 2025Break; Break

    IT WAS REPORTED THAT "DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE COAGULATOR HOOK BROKE AND FELL INTO THE ABDOMINAL CAVITY. THE FRAGMENT WAS SPOTTED BY ENDOSCOPY AND REMOVED IN ITS ENTIRETY FROM THE ABDOMINAL CAVITY". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 21882659 ↗
  • MalfunctionMar 21, 2025Break; Break

    IT WAS REPORTED THAT PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY, USING A NON-DISPOSABLE LAPAROSCOPIC CAUTERY DEVICE "L" HOOK, TIP BROKE OFF OF HANDPIECE, WAS RETRIEVED BY MD WITH NO ISSUES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21663089 ↗
  • MalfunctionOct 25, 2023Break; Break

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE 37370DL HAD BROKEN INSIDE THE PATIENT'S BODY. THE USER HAD BEEN ABLE TO RETRIEVE ALL PIECES THAT THEY COULD FIND, AND NO HARM OCCURRED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18004650 ↗
  • MalfunctionJun 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE PATIENT HAD ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED ON THEM. A SMALL 1MM MISSING PLASTIC PIECE WAS FOUND AT THE TIP OF THE HOOK AT THE END OF THE PROCEDURE. A SIMILAR PIECE WAS FOUND IN THE SUCTION BOTTLE LATER. BUT WE CANNOT CONFIRM IT IS THE MISSING PART OF THE HOOK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17060265 ↗
  • MalfunctionNov 4, 2022Material Separation; Material Separation

    THE EVENT OCCURRED IN CHINA: IT WAS REPORTED THAT THE HOOK WAS BROKEN DURING SURGERY. THE BROKEN PART FELL INTO THE PATIENT'S BODY BUT COULD SUCCESSFULLY BE RETRIEVED. NO HARM TO PATIENT, USER OR THIRD REPORTED. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15735415 ↗
  • InjuryNov 4, 2022Material Separation; Material Separation

    THE EVENT OCCURRED IN CHINA: IT WAS REPORTED THAT THE HOOK WAS BROKEN DURING SURGERY. THE BROKEN PART FELL INTO THE PATIENT'S BODY BUT COULD SUCCESSFULLY BE RETRIEVED. NO HARM TO PATIENT, USER OR THIRD REPORTED. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15735365 ↗
  • MalfunctionNov 6, 2020Material Separation; Material Separation

    ALLEGEDLY PER THE CUSTOMER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE ITEM BROKE AT TIP WHILE INSIDE THE PATIENT. THE PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO OTHER INTERVENTION AND NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10804377 ↗
  • MalfunctionJul 24, 2020Material Fragmentation; Material Fragmentation

    AS PER A MANUFACTURE INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4) WHICH WAS FILED WITH THE (B)(4): DURING THE OPERATION, THE HOOK DETACHED FROM THE HOOK ELECTRODE AND COULD NO LONGER BE FOUND IN THE PATIENT.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 10323250 ↗
  • MalfunctionJan 27, 2020Material Fragmentation; Material Fragmentation

    PER THE FACTORY IN (B)(4), ALLEGEDLY THERE WAS AN EVENT WHICH OCCURRED IN (B)(6) THAT THE HOOK BROKE OFF AND WAS INTRAOPERATIVE.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 9634181 ↗
  • MalfunctionDec 6, 2019Material Separation; Material Separation

    ALLEGEDLY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE L HOOK TIP OF THE ELECTRODE FELL INSIDE THE PATIENT; THE DOCTOR WAS ABLE TO RETRIEVE THE PIECE SUCCESSFULLY WITH NO HARM TO THE PATIENT AND THE PROCEDURE COMPLETED.

    Patient problems: Foreign Body In Patient

    MAUDE report 9432345 ↗
  • MalfunctionOct 18, 2019Material Separation; Material Separation

    ALLEGEDLY PER THE CUSTOMER, DURING A LAPAROSCOPIC SIGMOID RESECTION THE INSTRUMENT DISINTEGRATED, ITEM BROKE AT TIP WHILE INSIDE THE PATIENT. THE PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO OTHER INTERVENTION AND NO HARM TO THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9210085 ↗

Other COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES) devices

All COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.