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NA 270120Recalls & reported problems

Medos International Sàrl · Grasper - Grabber · Class 1

Quick summary

This Medos grasper-grabber is a manual surgical instrument used to hold and pull tissue during surgery, most often in shoulder and hip procedures. The 43 adverse event reports mostly describe the instrument breaking during surgery, or jaws that would not open and close, and on one occasion a loose jaw was found before the operation. There are no deaths and 1 injury reported. In most cases the broken pieces were retrieved and the surgery continued without delay. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
44
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10886705013968), received between Jan 21, 2017 and Sep 1, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Break” (23 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: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break23
  • Difficult to Open or Close19
  • Use of Device Problem2
  • Material Deformation1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions28
  • No Consequences Or Impact To Patient15
  • No Known Impact Or Consequence To Patient2
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50550462 ↗
  • MalfunctionJan 14, 2026Difficult to Open or Close

    IT WAS REPORTED THAT THE GRASPER-GRABBER -NS DEVICE IT WAS NOT POSSIBLE TO OPEN AND CLOSE THE FORCEPS TIP IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24070255 ↗
  • MalfunctionDec 16, 2025Break; Break

    IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY FOR DISLOCATION, THE GRASPER-GRABBER -NS BROKE WHEN THE SURGEON ATTEMPTED TO TIE THE SUTURE WHILE PULLING UP THE LABRUM. ACCORDING TO THE REPORTER, IT WAS THOUGHT THAT THE BONE HAD BEEN PINCHED BETWEEN THE BONE HEAD AND EXCESSIVE FORCE HAD BEEN APPLIED. ALL BROKEN PIECES WERE RETRIEVED AND VISUALLY INSPECTED BY NURSES AND SURGEONS ON THE INSTRUMENT TABLE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23818835 ↗
  • MalfunctionJul 24, 2025Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

    IT WAS REPORTED THAT THE GRASPER-GRABBER -NS DEVICE WAS BROKEN. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT OPEN/CLOSE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22586958 ↗
  • MalfunctionMar 10, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE GRASPER-GRABBER -NS DEVICE BROKE. IT WAS REPORTED THAT THE DEVICE BROKE WHILE GRASPING TISSUE, ALTHOUGH THERE WAS NO SPECIFIC FORCE APPLIED AT THE TIME. THERE WERE NO RESIDUAL TISSUE FRAGMENTS LEFT INSIDE THE BODY, AND THE BREAK DID NOT INTERFERE WITH THE SURGERY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21561649 ↗
  • MalfunctionAug 15, 2024Use of Device Problem; Difficult to Open or Close; Use of Device Problem; Difficult to Open or Close

    IT WAS REPORTED THAT PREOPERATIVELY TO A SHOULDER PROCEDURE, IT WAS OBSERVED THAT THE GRASPER GRABER WAS BROKEN/NOT WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE JAW ON THE DEVICE WAS LOOSE; AND IT WOULD NOT CLOSE WHEN THE HANDLE WAS PRESSED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19991927 ↗
  • MalfunctionApr 23, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE GRASPER-GRABBER -NS DEVICE TOP JAW WAS BROKEN OFF. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19163976 ↗
  • MalfunctionMar 15, 2024Break; Break

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GRASPER-GRABBER DEVICE TIP WAS BROKEN. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18911909 ↗
  • MalfunctionJan 4, 2024Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE GRASPER-GRABBER DEVICE OPENING ELEMENT WAS FAULTY AND COULD NOT BE OPENED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18442845 ↗
  • MalfunctionOct 19, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE GRASPER-GRABBER -NS DEVICE GRABBER BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17965847 ↗
  • MalfunctionJun 20, 2023Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MOVEMENTS ON THE GRASPER - GRABER DEVICE WERE NOT LINKED TO THE OPENING AND CLOSING OF THE FORCEPS. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17163570 ↗
  • MalfunctionApr 12, 2023Break; Break

    IT WAS REPORTED \BY THE AFFILIATE IN JAPAN THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MAXILLARY PART ON THE GRASPER - GRABER DEVICE BROKE WHEN THE ROTATOR CUFF WAS GRABBED AND PULLED. ACCORDING TO THE REPORT, THE BROKEN PART ENTERED THE SHOULDER JOINT BUT WAS LATER REMOVED AND CONFIRMED BY X-RAY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16727425 ↗
  • MalfunctionMar 7, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP THAT THE GRASPER - GRABER DEVICE BROKE AT THE JAW. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16495989 ↗
  • MalfunctionFeb 10, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRASPER - GRABER DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16354790 ↗
  • MalfunctionJan 26, 2023Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TOP JAW ON THE GRASPER - GRABER DEVICE WAS NOT OPENING OR CLOSING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16250034 ↗
  • MalfunctionDec 9, 2022Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE JAW ON THE GRASPER - GRABER DEVICE WOULD NOT CLOSE ALL THE WAY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15954133 ↗
  • MalfunctionAug 25, 2022Material Deformation; Material Deformation

    IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE UPPER JAW WAS BENT AND THE TEETH WERE NOT ENGAGED ON THE ON THE GRASPER - GRABER DEVICE THAT IT WAS NOT POSSIBLE TO GRASP THE TISSUE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15293806 ↗
  • MalfunctionFeb 18, 2022Break; Break

    IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRASPER-GRABBER DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13559383 ↗
  • MalfunctionFeb 7, 2022Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE JAW ON THE GRASPER-GRABBER DEVICE WOULD NOT CLOSE PROPERLY TO HOLD THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13475225 ↗
  • MalfunctionDec 10, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TOP JAW ON THE GRASPER-GRABBER DEVICE BROKE OFF INSIDE THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO GRAB THE BROKEN PIECE OUT AND TO COMPLETE THE PROCEDURE WITH A TWO-MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12977280 ↗
  • MalfunctionNov 23, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SPRING ON THE GRASPER-GRABBER DEVICE BROKE WHILE GRASPING THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12862594 ↗
  • MalfunctionOct 5, 2021Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE SALES REP THAT BEFORE AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT GRASPER-GRABBER DEVICE WAS NOT CLOSING NOR OPENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12578186 ↗
  • MalfunctionSep 2, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE OF THE RIGHT SHOULDER ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRASPER-GRABBER DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12415329 ↗
  • MalfunctionMay 13, 2021Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED BY THE SALES REP THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE JAW OF THE GRASPER-GRABBER DEVICE WAS NOT CLOSING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11819436 ↗
  • MalfunctionMar 2, 2021Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT ONE OF THE JAWS ON THE GRASPER-GRABBER DEVICE BROKE OFF. THE FRAGMENT WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11400203 ↗

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