NOVADAQ and PINPOINT SC9104Recalls & reported problems
Novadaq Technologies Inc · Pinpoint Laparoscope - 10mm, Standard, 0 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00858701006056), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Poor Quality Image” (1 report).
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 Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING A PROCEDURE THE IMAGE QUALITY WAS CLOUDY/GRAINY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE CASE, RESULTING IN A 1-2 MINUTE DELAY WHILE CONNECTING THE REPLACEMENT. THERE WAS A PATIENT INVOLVED; HOWEVER, THEY DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14940367 ↗
Other System, X-Ray, Angiographic devices
- ARTIS icono ceiling 11328100Siemens Healthcare GmbH · System, x-ray, angiographic9 recalls1 report
- Artis Q ceiling 10848281Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls1 death49 reports
- Artis Q floor 10848280Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls18 reports
- Artis zee biplane 10094141Siemens Healthcare GmbH · System, x-ray, angiographic3 recalls63 reports
- Artis Q.zen ceiling 10848354Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls10 reports
- Artis Q.zen floor 10848353Siemens Healthcare GmbH · System, x-ray, angiographic4 recalls5 reports
- Artis zee floor MN 10094142Siemens Healthcare GmbH · System, x-ray, angiographic2 recalls0 reports
- iMRX System iMRX System AR-DR MR30RSIMRIS Imaging, Inc. · System, X-Ray, Angiographic1 recall0 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page