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

Model Number 176645

Device Problems Failure to Align (2522); Difficult to Open or Close (2921)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic procedure, the device jaws were not aligned therefore the bottom jaw caused artery injury.The jaws curvature or bending was very visible and clear and not closing fully.The surgical time and duration of anesthesia were extended due to issue.Another device was used to complete the procedure.

Manufacturer Narrative

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

Event Description

According to the reporter, as per the additional information received, the injured part was a clip form.No patient injury.The patient was discharged from the hospital.

Event Description

According to the reporter, during laparoscopic procedure, the device jaws were not aligned therefore the bottom jaw caused artery injury.The injured part was a clip from.The injured artery was clipped with another clip applier to resolve the problem.The jaws curvature or bending was very visible and clear and not closing fully.The surgical time and duration of anesthesia were extended due to issue.Another device was used to complete the procedure.Patient is fine with no injury/harm.The patient was discharged from the hospital.

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 jaw misaligned.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.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
• MDR Report Key: 7161627
• MDR Text Key: 96327494
• Report Number: 2647580-2018-00068
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000747
• UDI-Public: 20884523000747
• Combination Product (y/n): N
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P6K0657X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/25/2017; 02/27/2018
• Supplement Dates FDA Received: 01/18/2018; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other