MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO DISSECT MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 176645

Device Problems Bent (1059); Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 12/04/2017

Event Type  Malfunction  

Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the device had curved jaws that caused unwanted tissue cauterizations. Two different devices were opened in the same case, but both the dissector could not be fully closed. Another device was used to complete the procedure. The duration of the anesthesia was extended because of the device replacement, thus extending the surgical time for 30 minutes or more.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the device had curved jaws that caused unwanted tissue cauterizations. Two different devices were opened in the same case, but both the dissector could not be fully closed. Another device was used to complete the procedure. The duration of the anesthesia was extended because of the device replacement, thus extending the surgical time for 30 minutes or more. There was a small amount of tissue damage due to the cauterization. Patient is alive.

• Brand Name: ENDO DISSECT
• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7140871
• MDR Text Key: 95621038
• Report Number: 2647580-2017-09100
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (Y/N): N
• Reporter Country Code: TU
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL,U

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/21/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 176645
• Device Catalogue Number: 176645
• Device LOT Number: P6J0824X
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial