INSTRUMENT 6541-4-800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327241082), received between May 17, 2022 and May 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2022Device Reprocessing Problem; Moisture or Humidity Problem

  A SURGICAL TECHNOLOGIST DISCOVERED THE SLIGHTEST MOISTURE COATING INSIDE THE FEMALE ADAPTOR END OF STRYKER T-HANDLE 6541-4-800 (GTIN (B)(4)) PICTURE A. I OPENED A SECOND SET, AND AN IDENTICAL T-HANDLE HAD THE SAME PROBLEM. NO OTHER INSTRUMENT IN EITHER SET HAD MOISTURE OF ANY TYPE. THE SURGICAL TECHNOLOGIST REMOVED THE TRAYS FROM SERVICE WITHOUT PATIENT CONTACT. SUBSEQUENT REPROCESSING OF T-HANDLE PER STRYKER IFU LED TO AN IDENTICAL OUTCOME. WE OPENED THE SETS IN STERILE PROCESSING FOLLOWING STERILIZATION TO LEARN WHETHER THE CONDITION EXISTED. THE SPD TEAM AGAIN FOUND MOISTURE IN THE FEMALE END OF THE DEVICE. REPROCESSING AND INCREASING STERILIZER DRYING TIME LED TO THE SAME RESULT: WATER INSIDE THE FEMALE END. WE REPROCESSED T-HANDLE AS A SINGLE ITEM PER IFU IN DOUBLE WRAP BLUE WRAP AND DOUBLE POUCHED PACK. THE MOISTURE PRESENCE WAS THE SAME. THE T-HANDLE PER THE IFU IS NOT TO BE DISASSEMBLED. TO FURTHER INVESTIGATE THE CAUSE OF THE MOISTURE, THE SPD TEAM TOOK APART THE T-HANDLE. OUR FINDINGS ARE WHAT PRECIPITATED THIS SUBMISSION. BEFORE DISASSEMBLY, THE T-HANDLE WENT THROUGH DECONTAMINATION. THE PROCESS INCLUDED MANUAL CLEANING, ULTRASONIC BATH, AND WASHER/CLEANER PROCESSING. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429993 ↗