NA 698339374Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034457123), received between Dec 29, 2020 and Jul 28, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING POST OP INSPECTION OF THE SETS IT WAS NOTICED THAT THE CLAMP WAS STRIPPED POSSIBLY FROM REGULAR WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MODIFIED INSTRUMENT RETRACTOR CLAMP ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121725 ↗
• MalfunctionJun 28, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE RETRACTOR CLAMP ASSEMBLY WAS CROSS THREADED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE CLAMP WAS JAMMED. THIS REPORT IS FOR A RETRACTOR CLAMP ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842233 ↗
• MalfunctionDec 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, WHEN SETTING UP RIGID ARM FOR CASE IT WAS NOTICED THAT THE PART WOULD NO LONGER TIGHTEN, AND IT BECAME CROSS THREADED. A BACK UP SET WAS PULLED; THERE WAS NO DISRUPTION TO THE CASE. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR A RETRACTOR CLAMP ASSEMBLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089408 ↗