PINPOINT PC9004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858701006568), received between Dec 14, 2018 and Sep 14, 2020 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K150956); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathSep 14, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THERE WAS PATIENT DEATH. PLEASE NOTE THAT THERE IS NO ALLEGED DEFICIENCY WITH THE REPORTED DEVICES AND IT CANNOT BE DETERMINED AT THIS TIME, WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

  Patient problems: Death; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10532268 ↗
• MalfunctionMar 5, 2019Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT ASSOCIATED WITH THE LIGHT CABLE.

  Patient problems: No Information

  MAUDE report 8390580 ↗
• MalfunctionFeb 8, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8322842 ↗
• MalfunctionDec 14, 2018Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Information

  MAUDE report 8165773 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150956. One submission often covers many models, so check the product and lot details in each record.

• Z-1428-2021 · Feb 26, 2021 · Terminated
  Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT sys