NA 242632Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10886705030187), received between Feb 15, 2019 and Aug 24, 2026 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (46 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418781 ↗
• MalfunctionJul 1, 2026Break; Use of Device Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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 25678255 ↗
• MalfunctionFeb 26, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE HD LAPSCP,EP,5.5,0,300 SCOPE DEVICE WAS 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 24460971 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WAS AN OBJECT INSIDE THE HD LAPSCP,EP,5.5,0,300 SCOPE IN THE FIELD OF VIEW. IT WAS REPORTED THAT THE OBJECT WAS PROBABLY A BROKEN ROD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401185 ↗
• MalfunctionJan 12, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,0,300 SCOPE DEVICE WAS DISPLAYING A CLOUDY IMAGE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032122 ↗
• MalfunctionJan 9, 2026Display or Visual Feedback Problem; Scratched Material

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP,EP,5.5,0,300 DEVICE WAS FOUND TO HAVE A LARGE SCRATCH AND ITS IMAGE APPEARED BLURRY. 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 24019373 ↗
• MalfunctionNov 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP,EP,5.5,0,300 DEVICE SCOPE WAS DIFFICULT TO SEE THROUGH AND COMPLETELY DARK. THEY REPLACED THE SCOPE AND COMPLETED 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 23585723 ↗
• MalfunctionOct 31, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE WAS BROKEN (2+ PIECES) : CHIPPED/SHAVED/DELAMINATED. IT WAS REPORTED IN THE SERVICE ORDER THAT THE INSIDE OF THE DEVICE OPTICS WERE LOOSE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23440155 ↗
• MalfunctionSep 12, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP,EP,5.5,0,300 DEVICE HAD A FOGGINESS THAT THE FACILITY COULD NOT GET RID OF. 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 23037407 ↗
• MalfunctionSep 4, 2025Crack; Use of Device Problem; Crack; Use of Device Problem

  IT WAS REPORTED THAT THE HD LAPSCP, EP DEVICE WAS CRACKED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962717 ↗
• MalfunctionAug 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HD LAPSCP DEVICE HAD A BIG GLARE IN THE SCOPE. THERE WERE NO REPORTS OF DELAYS TO THE PROCEDURE. 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 22819628 ↗
• MalfunctionAug 14, 2025Material Fragmentation; Unintended Movement; Material Fragmentation; Unintended Movement

  ITWAS REPORTED THAT DURING A LAPAROSCOPY SURGICAL PROCEDURE; IT WAS OBSERVED THAT THE HD LAPSCP DEVICE WAS WOBBLY. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN INTO TWO PIECES - WAS CHIPPED/SHAVED/DELAMINATED. 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 22803293 ↗
• MalfunctionAug 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING DEVICE TESTING IT WAS FOUND THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE HAD A HALF MOON IN IT. 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 22685621 ↗
• MalfunctionMay 19, 2025Crack; Display or Visual Feedback Problem; Crack; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE SCOPE WAS DEFECTED AND WAS BLACKED OUT. ACCORDING TO THE REPORTER, THE DEVICE LOOKED TO BE CRACKED. THERE WAS A DELAY OF SEVERAL MINUTES IN THE PROCEDURE REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043121 ↗
• MalfunctionMay 15, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE SCOPE WAS VERY CLOUDY. 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 22028623 ↗
• MalfunctionMay 1, 2025Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE WHILE USING THE HD LAPSCP, EP DEVICE THE USER OBSERVED THAT THERE MAY HAVE BEEN A BROKEN PIECE WITHIN THE LENS ITSELF CAUSING AN UNCLEAR IMAGE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE 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 21942084 ↗
• MalfunctionApr 1, 2025Display or Visual Feedback Problem; Material Deformation; Display or Visual Feedback Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE HD LAPSCP,EP DEVICE IMAGE WAS FOGGY AND THEY COULD NOT GET A CLEAN PICTURE. THEY NOTED THE SCOPE LOOKS BENT. THERE WAS NO DELAY IN THE PROCEDURE 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 21742909 ↗
• 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 21277798 ↗
• MalfunctionSep 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE HD LAPSCP,EP,5.5,0,300 DEVICE WAS CLOUDY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF 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 20150470 ↗
• 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,5.5,0,300 DEVICE WAS DAMAGED AND GIVING A FOGGY IMAGE (NOT CLEAR). IT WAS NOT USED DURING A SURGICAL 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 20085657 ↗
• MalfunctionJul 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED FROM THE AFFILIATE ON 7/5/2024 OUTSIDE OF SURGERY, IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE SCOPE WAS CLOUDY. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735156 ↗
• MalfunctionJul 2, 2024Break; Display or Visual Feedback Problem; Noise, Audible; Break; Display or Visual Feedback Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A LAPAROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE LENS ON THE LAPAROSCOPE, HIGH-DEFINITION EYE PIECE STYLE 5.5 MM X 0 DEGREES X 300 MM DEVICE WAS DAMAGED INTERNALLY AND HALF THE IMAGE WAS BLACK. THE DEVICE ALSO MADE A RATTLING SOUND WHEN SHAKEN. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656522 ↗
• MalfunctionMar 21, 2024Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT THE HD LAPSCP,EP,5.5,0,300 WAS LOOSE. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE FRACTURED, VISUAL: DEFORMED BENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952164 ↗
• MalfunctionJan 16, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT DURING TESTING ON (B)(6) 2023 IT WAS OBSERVED THAT TWO SCOPES WERE CLOUDY AND WERE UNABLE TO BE USED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518142 ↗
• MalfunctionDec 6, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT PRIOR TO STERILE PROCESSING, IT WAS OBSERVED THAT THE HD LAPSCP,EP,5.5,0,300 DEVICE HAD A RING THAT WAS VISIBLE WITH THE NAKED EYE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 18277102 ↗