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.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the jaws were difficult to open or close.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.

• 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
• UDI-Device Identifier: 10884523000740
• UDI-Public: 10884523000740
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• 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
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/06/2017; 02/27/2018
• Supplement Dates FDA Received: 01/05/2018; 12/16/2020
• 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
• Patient Sequence Number: 1