NOVADAQ and PINPOINT SC9134Recalls & reported problems
Novadaq Technologies Inc · Pinpoint Laparoscope - 10mm, Standard, 30 with Wolf and Storz adaptor · Class 2
All models of NOVADAQ and PINPOINT (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00858701006063), received between Sep 19, 2018 and Aug 26, 2022 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Poor Quality Image4
- Adverse Event Without Identified Device or Use Problem1
- Display or Visual Feedback Problem1
- Material Opacification1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE APPEARED BLURRY DURING A MEDICAL PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15306987 ↗InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PROCEDURE WAS RESCHEDULED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9593593 ↗MalfunctionNov 14, 2018Poor Quality Image
IT WAS REPORTED THAT THE LAPAROSCOPE WAS DELIVERING A FOGGY IMAGE DURING A MEDICAL PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETED THE PROCEDURE.
Patient problems: No Information
MAUDE report 8072071 ↗MalfunctionNov 2, 2018Material Opacification
IT WAS REPORTED THAT THE DEVICE WAS CLOUDY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8033960 ↗MalfunctionOct 1, 2018Poor Quality Image
IT WAS REPORTED THAT THE SCOPE SHOWED A POTENTIALLY DECREASED IMAGE OUTPUT TO AN UNKNOWN LEVEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO MEDICAL INTERVENTION OR SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7923317 ↗InjurySep 25, 2018Poor Quality Image
IT WAS REPORTED THAT THE SCOPE SHOWED POOR IMAGE RESULTING IN CONVERSION TO OPEN PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Code Available
MAUDE report 7907944 ↗MalfunctionSep 19, 2018Display or Visual Feedback Problem
IT WAS REPORTED THAT THE SCOPE SHOWED A DECREASED IMAGE OUTPUT TO AN UNKNOWN LEVEL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7890541 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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