NA 242636Recalls & reported problems
Medos International Sàrl · Laparoscope, High Definition Eye Piece style 10 mm x 30 DEGREES x 330 mm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705030224), received between Apr 25, 2022 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 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
Most reported problems
Device problems
- Display or Visual Feedback Problem3
- Crack1
- Poor Quality Image1
- Unintended Movement1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Display or Visual Feedback Problem
It was reported that the HD LAPSCP,EP,10,30,330 device appeared dim and dingy in the picture. There was no patient involvement. 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 50899857 ↗MalfunctionOct 19, 2022Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem
IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6)2022 , IT WAS OBSERVED THAT THE HD LAPAROSCOPE,EP,10MM,30 DEG X 330MM DEVICE HAD A SMALL FRACTURE ON IT THAT WAS VISIBLE ON THE DISPLAY SCREEN. 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 15633748 ↗MalfunctionApr 25, 2022Display or Visual Feedback Problem; Poor Quality Image; Use of Device Problem; Unintended Movement; Display or Visual Feedback Problem; Poor Quality Image; Use of Device Problem; Unintended Movement
IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE HD LAPSCP,EP,10,30,330 ENDOSCOPE DEVICE DID NOT WORK ANYMORE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD DISPLAYED A POOR QUALITY IMAGE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194262 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page