NA 5832S (UDI 00643169703346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169703346), received between Jul 12, 2018 and Jan 8, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 8, 2019Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT RECENTLY PURCHASED PATIENT SLAVING CABLES FOR THE ANALYZER HAVE EXHIBITED A HIGHER THAN EXPECTED RATE OF FAILURE (STATED AS 4 OUT OF THE 6 CABLES PURCHASED). IT WAS EXPLAINED THAT WHEN THESE CABLES WERE IN USE DURING AN IMPLANT PROCEDURE AN IMPEDANCE OF GREATER THAN 4000 OHMS WAS DISPLAYED. IT IS EXPECTED THAT THE CABLES WILL BE RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227105 ↗
• MalfunctionJan 8, 2019Impedance Problem; Material Integrity Problem; Impedance Problem; Material Integrity Problem

  IT WAS REPORTED THAT RECENTLY PURCHASED PATIENT SLAVING CABLES FOR THE ANALYZER HAVE EXHIBITED A HIGHER THAN EXPECTED RATE OF FAILURE (STATED AS 4 OUT OF THE 6 CABLES PURCHASED). IT WAS EXPLAINED THAT WHEN THESE CABLES WERE IN USE DURING AN IMPLANT PROCEDURE AN IMPEDANCE OF GREATER THAN 4000 OHMS WAS DISPLAYED. IT IS EXPECTED THAT THE CABLES WILL BE RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227074 ↗
• InjuryJul 12, 2018Failure to Capture; High impedance; Loose or Intermittent Connection; Device Sensing Problem; Material Integrity Problem; Device Sensing Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CLAWS OF THE SURGICAL CABLES WOULD TEND TO LOOSEN EASILY AFTER STERILIZATION. IT WAS INDICATED THAT THIS RESULTED IN LOSS OF CAPTURE WHILE THRESHOLD TESTING, HIGH IMPEDANCES AND VARIABLE SENSING. THE CABLES WERE RETURNED FOR ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7683066 ↗