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

Model Number 176645

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, pre operatively, the tip of the dissector was not aligning correctly.Product not up to standard.There was no patient involvement.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of six devices.Engineering verified that jaw alignment of devices was within specifications.Engineering inspected jaws under a microscope and found no physical damage to any of the jaws.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7429329
• MDR Text Key: 105421121
• Report Number: 2647580-2018-01823
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 10884523000740
• UDI-Public: 10884523000740
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P7H1974X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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