n.a. 26173AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04048551097755), received between Jun 6, 2017 and Dec 23, 2025 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT BROKEN, TIP FRACTURED DURING USE, FRAGMENT ENTERED PATIENT. IT WAS CONFIRMED THAT THE SURGEON WAS ABLE TO REMOVE THE FRAGMENT AND ABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878890 ↗
• InjuryApr 28, 2025Loss of or Failure to Bond; Break; Loss of or Failure to Bond; Break

  IT WAS REPORTED THAT DURING A CASE THE TIP OF THE DEVICE BROKE OFF INTO THE PATIENT. THE INCISION WAS ENLARGED TO SEARCH FOR AND REMOVE THE BROKEN PIECE FROM PATIENT'S ABDOMINAL TISSUE. PATIENT WAS UNDER A PROLONG ANESTHESIA DUE TO ADDITIONAL REMOVING BROKEN PIECE PROCEDURE AND X-RAYS CONFIRMATION AS THE END OF THE PROCEDURE. THE TIP WAS DISCARDED AS IT WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS PROLONGED BY 45 TO 60 MINUTES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921858 ↗
• InjuryApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A CASE THE TIP OF THE DEVICE BROKE OFF INTO THE PATIENT. THE INCISION WAS ENLARGED TO SEARCH FOR AND REMOVE THE BROKEN PIECE FROM PATIENT'S ABDOMINAL TISSUE. PATIENT WAS UNDER A PROLONG ANESTHESIA DUE TO ADDITIONAL REMOVING BROKEN PIECE PROCEDURE AND X-RAYS CONFIRMATION AS THE END OF THE PROCEDURE. THE TIP WAS DISCARDED AS IT WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS PROLONGED BY 45 TO 60 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 21921838 ↗
• MalfunctionApr 25, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PRODUCT WAS FOUND DEFECT OUT OF THE BOX. AN INTERNAL ASSESSMENT REVEALED THAT THE JAW PART IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915117 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT IS BROKEN. NO NEGATIVE IMPACT IN STATE OF PATIENT HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462419 ↗
• MalfunctionSep 18, 2024Break; Image Display Error/Artifact; Break; Image Display Error/Artifact

  IT WAS REPORTED DURING A MEDICAL PROCEDURE ON (B)(6) 2024, THE FASCIAL CLOSURE INSTRUMENT TIP BROKEN/MISSING. THE SURGON FOUND IT INSIDE OF THE SUBCUTANEUS FAT AND GENTLY RETURIEVED IT USING A HALSTED CLAMP. THE SURGERY WENT WELL WITH NO OTHER COMPLICATIONS MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247075 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT WHILE CLOSING THE TROCAR SITE DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE JAW OF THE BERCI NEEDLE BROKE OFF OF THE INSTRUMENT AND BECAME STUCK IN THE SUBCUTANEOUS TISSUE. SURGERY WAS STOPPED AND X-RAY WAS CALLED IN WITH A PORTABLE MACHINE. THE BROKEN PIECE WAS LOCATED UNDER FLUOROSCOPY AND REMOVED FROM THE SUBCUTANEOUS TISSUE. AFTER SURGERY, AND BEFORE LEAVING THE ROOM, AN ADDITIONAL X-RAY WAS TAKEN AND READ- THE X-RAY WAS DETERMINED TO BE CLEAR WITHOUT ANY RETAINED OBJECTS. THE BROKEN ITEM WILL BE TAKEN TO RISK MANAGEMENT FOR FURTHER EVALUATION. SOFT TISSUE INJURY TO ABDOMEN. CUSTOMER SUPPORT WILL CONTINUE TO FOLLOW THE INSTRUCTION FOR USE- SURGEON STATES THAT DURING THIS PROCEDURE HE WAS TRYING TO GO THROUGH MESH. THERE'S A POSSIBILITY THE DISTAL TIP OF THE BERCI CAUGHT THE MESH AND WITH PRESSURE APPLIED MAY HAVE CAUSED THE ISSUE. TEMPORARY HARM-MINIMAL. DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION- THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402025 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT THE BERCI CLOSURE DEVICE MALFUNCTIONED. THE CLOSURE DEVICE TIP BROKE OFF WITHIN THE SUBCUTANEOUS TISSUE. USING A C-ARM UNDER FLUOROSCOPY, THE TIP WAS LOCATED AND RETRIEVED FROM THE PATIENT'S BODY. A FINAL ABDOMINAL FILM WAS TAKEN AND CLEARED TO CONFIRM THERE WERE NO RETAINED FOREIGN OBJECTS. THE INSTRUMENT WAS REMOVED FROM SERVICE. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402024 ↗
• MalfunctionApr 3, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS EVENT WITH A 26173AM A FASCIAL CLOSURE INSTRUMENT 2.8MM, 17CM. ACCORDING TO THE INFORMATION RECEIVED VIA THE MEDWATCH REPORT 0501290000-2023-8001 AND THE FACILITY, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, AT CLOSING THE CLOSURE DEVICE BROKE OUTSIDE OF THE PATIENT ON THE STERILE FIELD. PER THE FACILITY NO PATIENT HARM AND PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664408 ↗
• InjuryNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ISSUE WITH A FASCIAL CLOSURE INSTRUMENT. THE JAW OF THE DEVICE BROKE OFF INTRAOPERATIVELY. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BREAKAGE OCCURRED DURING THE SUTURE. THE BROKEN PIECE GOT STUCK IN THE FASCIA OF THE ABDOMINAL WALL. THE BROKEN PIECE COULD BE RECOVERED. THIS HAS CREATED A CRITICAL SITUATION AND THE JAW MUST BE RECOVERED WITH CONSIDERABLE EFFORT. NO FURTHER DETAILS ON THE CRITICAL SITUATION AND THE EXACT EFFORT FOR RECOVERY ARE AVAILABLE. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794172 ↗
• InjuryNov 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ISSUE WITH THE A FASCIAL CLOSURE INSTRUMENT. THE JAW OF THE DEVICE BROKE OFF INTRAOPERATIVELY. ACCORDING TO THE COMPLAINT DESCRIPTION, THE BREAKAGE OCCURRED DURING THE SUTURE. THE BROKEN PIECE GOT STUCK IN THE FASCIA OF THE ABDOMINAL WALL. THE BROKEN PIECE COULD BE RECOVERED. THIS HAS CREATED A CRITICAL SITUATION AND THE JAW MUST BE RECOVERED WITH CONSIDERABLE EFFORT. NO FURTHER DETAILS ON THE CRITICAL SITUATION AND THE EXACT EFFORT FOR RECOVERY ARE AVAILABLE. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792926 ↗
• MalfunctionOct 7, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  THE MANUFACTORS COMPLAINT REFERENCE IS (B)(4). PER THE FACILITY, THE DEVICE WAS LOADED PROPERLY, HOWEVER WHEN DR. INSERTED THE DEVICE INTO THE ABDOMEN, UNDER LAPAROSCOPIC GUIDANCE, THE BOTTOM-POINTED TIP OF THE ENDOCLOSE DEVICE BROKE OFF INSIDE THE PATIENT INTO THE ABDOMEN. THE PIECE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS AND MANAGEMENT WAS NOTIFIED. NO INFORMATION OF HARM TO PATIENT, USER OR THIRD WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15562325 ↗
• MalfunctionJul 13, 2022Break; Break

  PER MEDWATCH REPORT #MW5110030 RECEIVED VIA EMAIL ON 6/15/22: KARL STORZ 26173AM BERCI FASCIAL CLOSURE DEVICE, 2.8 MM X 17 CM, LOT # HE 2, TIP BROKE OFF INTRAOPERATIVELY WHILE CLOSING SURGICAL WOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003860 ↗
• MalfunctionApr 2, 2021Material Separation; Material Separation

  DURING A LAPAROSCOPIC VERTICAL OR PARTIAL GASTRECTOMY PROCEDURE, THE TIP OF THE INSTRUMENT BROKE IN THE FATTY LAYERS OF THE PATIENT. ATTEMPTS WERE MADE WITH ULTRASOUND AND PALPATIONS TO LOCATE THE DEVICE TIP. THE DOCTOR WAS UNABLE TO RETRIEVE THE PIECE FROM THE PATIENT. THE DOCTOR DECIDED TO LEAVE THE TIP INSIDE AND INFORMED THE PATIENT . AN X-RAY WAS TAKEN IN RECOVERY WHICH WAS ALSO NEGATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11611040 ↗
• MalfunctionSep 11, 2020Break

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): TIP BROKEN DURING A LAPAROSCOPIC PROCEDURE. THE TIP WAS RETRIEVED THROUGH A SLIGHTLY INCREASED INCISION.

  Patient problems: Tissue Damage

  MAUDE report 10525521 ↗
• MalfunctionNov 13, 2019Material Separation; Material Separation

  ALLEGEDLY, DURING A LAPAROSCOPIC ROBOT ASSISTED INCARCERATED INCISIONAL HERNIA REPAIR PROCEDURE, AT THE END OF THE CASE, IT WAS NOTICED THE TIP OF THE ENDO-CLOSURE DEVICE HAD FRACTURED OFF INSIDE THE PATIENT. ATTEMPTS WERE MADE WITH THE C-ARM AND PALPATION OF THE ABDOMINAL WALL TO LOCATE THE DEVICE TIP. THE DOCTOR WAS UNABLE TO RETRIEVE THE PIECE FROM THE PATIENT. THE DOCTOR DECIDED TO LEAVE THE TIP AS IT WAS SUCH A SMALL OBJECT WITHIN THE ABDOMINAL WALL AS THE RISK TO REMOVE WAS GREATER THAN THE BENEFIT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9316578 ↗
• MalfunctionApr 5, 2019Mechanical Problem; Mechanical Problem

  ALLEGEDLY, THE TIP BROKE OFF IN THE PATIENT DURING A PROCEDURE. THEY WERE ABLE TO RETRIEVE ALL BROKEN PARTS AND IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 8489560 ↗
• MalfunctionDec 13, 2017Break; Detachment Of Device Component; Material Separation; Material Separation

  ALLEGEDLY, AT THE END OF A LAPAROSCOPIC VERTICAL SLEEVE GASTRECTOMY, POSSIBLE LIVER BIOPSY, LAPAROSCOPIC/POSSIBLE OPEN CHOLECYSTECTOMY PROCEDURE, THE JAW OF THE FASCIA CLOSURE DEVICE BROKE OFF INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED IN APPROXIMATELY 20 MINUTES. HOSPITAL REPORTED THE PATIENT IS DOING FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7115817 ↗
• MalfunctionOct 30, 2017Material Separation; Material Separation

  ALLEGEDLY, THE TIP OF THE INSTRUMENT BROKE OFF IN THE PATIENT DURING A PROCEDURE. X-RAY WAS DONE AFTERWARDS AND THE BROKEN TIP WAS FOUND LODGED IN THE PATIENT'S ABDOMINAL TISSUE. THE PIECE WAS NOT RETRIEVED AND HOSPITAL STATES THE SURGEON DISCLOSED THIS TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 6989076 ↗
• MalfunctionJul 6, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING A ROBOTICS CASE, ONE JAW OF THE INSTRUMENT BROKE OFF INTO PATIENT; THE DOCTOR RETRIEVED THE PIECE AND WENT ON TO COMPLETE PROCEDURE. THE HOSPITAL REPORTED NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6691313 ↗
• MalfunctionJun 6, 2017Material Separation; Material Separation

  ALLEGEDLY, THE DOCTOR WAS PERFORMING A LAP APPENDECTOMY WHEN A JAW BROKE OFF INSTRUMENT INTO PATIENT. THEY USED A C-ARM TO LOCATE THE BROKEN PIECE AND THE DOCTOR REMOVED IT. THERE WAS A 30 MINUTE DELAY WHICH CAUSED NO INJURY TO THE PATIENT. HE WENT ON TO COMPLETE PROCEDURE. THE HOSPITAL REPORTS THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616856 ↗