NA 03.612.031Recalls & reported problems
Synthes GmbH · FIBER OPTIC LIGHT CABLE · Class 1
Data updated Oct 16, 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 10705034714530), received between May 6, 2021 and May 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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 16, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
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.
MalfunctionMay 6, 2021Material Integrity Problem; Material Integrity Problem
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE LIGHT SOURCE CABLE WAS TESTED TO VERIFY ITS CONDITION. THE CABLE HAD MICRO-BREAKS THAT LET THE LIGHT ESCAPE. THERE WAS NO INVOLVEMENT WITH THE PATIENT, NO DELAYS, OR ADVERSE EVENTS. THIS REPORT IS FOR ONE (1) FIBER OPTIC LIGHT CABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11783287 ↗
Other RETRACTOR, FIBEROPTIC devices
- InnerVision® 1465-50Diversatek Healthcare, Inc. · Retractor, Fiberoptic3 reports
- Snowden-Pencer 88-1087Steris Corporation · RETRACTOR, FIBEROPTIC3 reports
- Snowden-Pencer 88-1086Steris Corporation · RETRACTOR, FIBEROPTIC2 reports
- Snowden-Pencer 88-1088Steris Corporation · RETRACTOR, FIBEROPTIC2 reports
- Snowden-Pencer 88-1090Steris Corporation · RETRACTOR, FIBEROPTIC1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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