SNAP CLAMP ASSEMBLY

Description of Event or Problem

A FACILITY ENGINEER REPORTED THAT THE CLAMPING FORCE OF THE SNAP CLAMP ASSEMBLY (4040) ON THE RETRACTOR ROD WAS "TOO LOW, THAT THE CLAMP YIELDS TO TISSUE PRESSURE." THERE WAS NO PATIENT INJURY; HOWEVER, A SURGICAL DELAY EXCEEDING 30 MINUTES WAS REPORTED.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

UPDATED FIELDS: D9, G3, G6, H2, H3, H4, H6, H11. THE SNAP CLAMP ASSEMBLY (4040) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WAS OBSERVED. FAILURE ANALYSIS: THE CUSTOMER'S STATEMENT WAS CONFIRMED AS VALID AFTER EVALUATING THE DEVICE. "THE INSPECTION OF THE SNAP CLAMP REVEALS THAT IT IS NOT CLOSING PROPERLY AND HAS BECOME LOOSE. THE BOLT MUST BE REPLACED ALONG WITH THE WORN WASHERS, AND THE UNIT MUST BE READJUSTED ACCORDING TO THE MANUFACTURER'S SPECIFICATIONS. PRODUCT WEAR AND TEAR DUE TO NORMAL USE IS EXCLUDED FROM THE TERMS OF THE OMNI-TRACT WARRANTY. THIS REPAIR IS NOT COVERED BY THE WARRANTY. THE UNIT MUST BE FUNCTIONALLY CHECKED AND MARKED WITH THE INSTANCE NUMBER (B)(4)." ROOT CAUSE ANALYSIS: THE REPORTED COMPLAINT WAS CONFIRMED. BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE IS MOST LIKELY HEAVY WEAR AND MISHANDLING OVER TIME, RESULTING IN FUNCTION-INHIBITING DAMAGE.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

UPDATED FIELDS: G3, G6, H2, H11. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WAS OBSERVED. COULD NOT BE PERFORMED AT THIS TIME AS NOT ENOUGH LOT/SERIAL/MANUFACTURE DATE INFORMATION WAS PROVIDED. THE NUMBER PROVIDED IS ONLY A LOT CODE. THE DHR MAY BE REVIEWED, IF NECESSARY, IF/WHEN ENOUGH FURTHER INFORMATION IS PROVIDED OR CAN BE IDENTIFIED.