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 Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The issues with both devices occurred prior to a laparoscopic cholecystectomy procedure during preparation.For the dissecting device, the distal jaw tips are a little twisted.For the clinching device, the latchet function does not work.In order to resolve the issue and complete the case, replaced with new devices.There was no patient harm.The patient status is alive, no injury.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The jaws were within the standard manufacturing sop of 0.020¿ and do not affect the functional use of the product.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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 6487549
• MDR Text Key: 72662151
• Report Number: 2647580-2017-05271
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 10884523000740
• UDI-Public: 10884523000740
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2017

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: 02/28/2021
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P6B0587X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided; 06/21/2017; 06/21/2017
• Supplement Dates FDA Received: 06/07/2017; 07/19/2017; 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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