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NA 242633Recalls & reported problems

Medos International Sàrl · Laparoscope, High Definition Eye Piece style 5.5 mm x 30 DEGREES x 300 mm · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This is a Medos high-definition laparoscope scope. The 50 reports mostly describe visual problems — cloudy or blurry images, a loose lens, objects inside the scope — and scopes found chipped, shaved or delaminated, sometimes broken into pieces. No deaths or injuries were reported, and 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
54
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886705030194), received between Feb 15, 2019 and Sep 21, 2026 — classified as 54 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (37 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: 1 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 4 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 3 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 4 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Display or Visual Feedback Problem37
  • Break12
  • Material Fragmentation3
  • Appropriate Device Problem Term/Code Not Available2
  • Moisture Damage2
  • Poor Quality Image2
  • Use of Device Problem2
  • Crack1

Patient problems

  • No Clinical Signs, Symptoms or Conditions51
  • No Consequences Or Impact To Patient2
  • Not Applicable1

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 21, 2026Material Fragmentation; Scratched Material

    It was reported that during in-house engineering evaluation, it was determined that the HD LAPSCP,EP,5.5,30,300 device was chipped/shaved/delaminate. It was noted by the reporter that the device was scratched. There was no patient involvement. 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 2026. All available information has been disclosed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50846282 ↗
  • MalfunctionSep 21, 2026Display or Visual Feedback Problem

    It was reported that during an unspecified surgical procedure it was observed that the HD LAPSCP,EP,5.5,30,300 scope was producing a fuzzy image. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50839288 ↗
  • MalfunctionSep 17, 2026Display or Visual Feedback Problem

    It was reported that during an unspecified arthroscopic procedure the HD LAPSCP, EP, 5.5, 30, 300 endoscope device had very cloudy image. Another device was used to complete the procedure. There was no delay in the procedure reported. There were no adverse patient consequences reported. All available information has been disclosed.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50805001 ↗
  • MalfunctionSep 10, 2026Display or Visual Feedback Problem; Use of Device Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50717821 ↗
  • MalfunctionJul 17, 2026Display or Visual Feedback Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25854685 ↗
  • MalfunctionJun 17, 2026Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE HD LAPSCP, EP, 5.5, 30, 300 SCOPE DEVICE IS CLOUDY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25536294 ↗
  • MalfunctionApr 24, 2026Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HD LAPSCP,EP,5.5,30,300 DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNKNOWN ISSUE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24984412 ↗
  • MalfunctionApr 24, 2026Material Fragmentation; Moisture Damage

    IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HD LAPSCP,EP,5.5,30,300 DEVICE WAS CHIPPED/SHAVED/DELAMINATED. IT WAS INITIALLY REPORTED THAT DURING A LAPAROSCOPY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT MULTIPLE DEVICES DID NOT FUNCTION TO THE DOCTOR'S EXPECTATIONS; THEY SWAPPED DEVICES, BUT ISSUES PERSISTED. THE SURGERY WAS COMPLETED, AND THE NEXT SURGERY WAS CANCELLED DUE TO THESE ISSUES. CAMERA IMAGES WERE BLURRY AND COULD NOT BE FOCUSED ACROSS THE ENTIRE FIELD OF VIEW. LIGHT FROM THE LIGHT CORDS WAS DIM. THE COUPLERS WERE NOT FOCUSING AND THERE APPEARED TO BE FLUID INGRESS IN THE SCOPES. 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 24984385 ↗
  • MalfunctionApr 24, 2026Material Fragmentation; Moisture Damage

    IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HD LAPSCP,EP,5.5,30,300 DEVICE WAS CHIPPED/SHAVED/DELAMINATED. IT WAS INITIALLY REPORTED THAT DURING A LAPAROSCOPY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT MULTIPLE DEVICES DID NOT FUNCTION TO THE DOCTOR'S EXPECTATIONS; THEY SWAPPED DEVICES, BUT ISSUES PERSISTED. THE SURGERY WAS COMPLETED, AND THE NEXT SURGERY WAS CANCELLED DUE TO THESE ISSUES. CAMERA IMAGES WERE BLURRY AND COULD NOT BE FOCUSED ACROSS THE ENTIRE FIELD OF VIEW. LIGHT FROM THE LIGHT CORDS WAS DIM. THE COUPLERS WERE NOT FOCUSING AND THERE APPEARED TO BE FLUID INGRESS IN THE SCOPES. 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 24984345 ↗
  • MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HD LAPSCP,EP,5.5,30,300 DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24747217 ↗
  • MalfunctionFeb 19, 2026Break

    IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE HD LAPSCP,EP,5.5,30,300 SCOPE DEVICE, THAT THERE IS AN OBJECT INSIDE THE SCOPE IN THE FIELD OF VIEW, PROBABLY A BROKEN ROD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24393524 ↗
  • MalfunctionJan 9, 2026Display or Visual Feedback Problem; Unintended Movement

    IT WAS REPORTED THAT THE LENS OF THE HD LAPSCP,EP,5.5,30,300 SCOPE DEVICE WAS LOOSE CAUSING THE IMAGE TO BE POOR. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24021745 ↗
  • MalfunctionDec 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE COUPLER AC ZOOM DEVICE HAD PARTICLES IN THE LENS SO WHEN HOOKED UP, IT LOOKED LIKE THERE WERE DOTS ON THE SCREEN. THE HD LAPSCP,EP,5.5,30,300 DEVICE IMAGE WAS GRAINY AND CLOUDY. THE HD LAPSCP,EP,5.5,30,300 DEVICE HAD NO LIGHT COMING FROM THE CORD. IT IS UNKNOWN WHETHER THERE WERE OTHER DEVICES AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 3 FOR THE SAME EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23888248 ↗
  • MalfunctionDec 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE COUPLER AC ZOOM DEVICE HAD PARTICLES IN THE LENS SO WHEN HOOKED UP, IT LOOKED LIKE THERE WERE DOTS ON THE SCREEN. THE HD LAPSCP,EP,5.5,30,300 DEVICE IMAGE WAS GRAINY AND CLOUDY. THE HD LAPSCP,EP,5.5,30,300 DEVICE HAD NO LIGHT COMING FROM THE CORD. IT IS UNKNOWN WHETHER THERE WERE OTHER DEVICES AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR THE SAME EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23888246 ↗
  • MalfunctionOct 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS REPORTED THAT THERE WAS FOGGINESS INSIDE THE HD LAPSCP, EP,5.5,30,300 SCOPE THAT COULD NOT BE REMOVED. IT WAS REPORTED THAT THERE WAS A SEVERAL MINUTES DELAY UNTIL ANOTHER SCOPE WAS BROUGHT INTO THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23302888 ↗
  • MalfunctionSep 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE SCOPE ON THE HD LAPSCP,EP,5.5,30,300 DEVICE PRODUCED A DARK AND GRAINY IMAGE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 23030706 ↗
  • MalfunctionSep 8, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SCOPE ON THE HD LAPSCP, EP, 5.5, 30, 300 DEVICE WAS PRODUCING A GRAINY IMAGE, AND THE CAMERA WAS NOT FUNCTIONING PROPERLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT SPARE DEVICES WERE USED TO COMPLETE THE SURGERY. 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 22993142 ↗
  • MalfunctionJun 6, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP,EP,5.5,30,300 DEVICE HAD A FOGGINESS THAT STERILE PROCESSING COULD NOT REMOVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNSPECIFIED DELAY REPORTED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22160203 ↗
  • MalfunctionMay 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,30,300 LIGHT CORD DEVICE WAS NOT TRANSMITTING LIGHT AND THE ENDOSCOPE DEVICE WAS DEFECTIVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22116950 ↗
  • MalfunctionMay 28, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS FOUND THAT THE SCOPE OF THE HD LAPSCP, EP, 5.5, 30, 300 DEVICE REMAINED BLURRY, DESPITE ATTEMPTS BY THE STERILE PROCESSING DEPARTMENT TO POLISH IT. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 22099903 ↗
  • MalfunctionApr 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING STERILE PROCESSING IT WAS OBSERVED THAT THE HD LAPSCP, EP, 5.5, 30, 300 ENDOSCOPE DEVICE WAS CLOUDY. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 21890990 ↗
  • MalfunctionMar 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP DEVICE THE SCOPE HAD A GRAINY IMAGE AND THE LIGHT CORD WAS NOT BRIGHT. THE SCOPE WAS REPLACED AND THE GRAINY IMAGE IMPROVED BUT NOT THE BRIGHTNESS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. 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 21663646 ↗
  • MalfunctionJan 30, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A LAPROSCOPIC CHOLE PROCEDURE, IT WAS OBSERVED THAT THE DEVICE HAD FOGGINESS THAT THE FACILITY COULD NOT GET RID OF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21277943 ↗
  • MalfunctionJan 14, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, IT WAS DISCOVERED THAT THE HD LAPSCP,EP,5.5,30,300 DEVICE EXHIBITED FOGGINESS THAT THE FACILITY WAS UNABLE TO RESOLVE. ADDITIONALLY, IT WAS NOTED THAT THE SURGERY EXPERIENCED A DELAY OF SEVERAL MINUTES WHILE ANOTHER CAMERA WAS RETRIEVED. 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 21150371 ↗
  • MalfunctionAug 28, 2024Display or Visual Feedback Problem; Use of Device Problem; Display or Visual Feedback Problem; Use of Device Problem

    IT WAS REPORTED BY THE SALES REP THAT ON AN UNKNOWN DATE THE HD LAPSCP,EP,5.5,30,300 DEVICE WAS DAMAGED AND GIVING A FOGGY IMAGE/NOT CLEAR. 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 20086257 ↗

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