MAUDE Adverse Event Report: MEDTRONIC ENDOCLIP; CLIP, IMPLANTABLE

Catalog Number 176625

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

During a laparoscopic hand assisted nephrectomy, the endoclip applier broke; the handle portion came apart at the seam.The device was removed from the field and a new one was opened.There was no patient injury or delay in procedure.The broken device was given to the representative with the request to have the device inspected and report sent to facility.The wrapper with the lot number was not saved.The lot number is not available.Follow up from company representative: the trigger of the device simply broke because it had been squeezed too hard, but it was still attached and nothing broke off the device.I have been reminding staff to be more gentle with this in the future.

• Brand Name: ENDOCLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9145510
• MDR Text Key: 160887322
• Report Number: 9145510
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019,09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 176625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 66