LAPO-CLAMP II
Received Sep 21, 2022
Report 3004608878-2022-00191 · MDR key 15461694
Device
Product problems
- Separation Problem
- Separation Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A FACILITY REPORTED THAT ONE PIECE OF THE LAPO-CLAMP II (3900) FELL OFF DURING SURGERY AND ONTO THE PATIENT. ALL PARTS WERE RECOVERED. THE BROKEN COMPONENT WAS REPLACED TO FINISH THE CASE. THE EVENT DID NOT LEAD TO PATIENT INJURY; HOWEVER, AN UNSPECIFIED DELAY IN SURGERY 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.
Additional Manufacturer Narrative
THE SUSPECTED LAPO-CLAMP II (3900) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE NOR REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT PERFORMED. A POSSIBLE ROOT CAUSE OF A PIECE FALLING OFF DURING SURGERY COULD BE USE ERROR, HOWEVER THIS IS UNABLE TO BE CONFIRMED WITHOUT BEING ABLE TO EVALUATE THE PIECE THAT ALLEGEDLY FELL OFF DURING SURGERY. THE ROOT CAUSE, THEREFORE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.