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

Model Number 176645

Device Problems Mechanical Problem (1384); Failure to Align (2522); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter: occurred during a laparoscopic cholecystectomy procedure.When the device was removed from the packaging, noticed that the jaws were not closed properly.The two jaws did not come up / coincide exactly to each other.The device did not grasp properly.The device was not used on the patient.In order to resolve the issue and complete the case, replaced with a new device.There was no patient harm.The patient outcome is reported as alive, no injury.

Manufacturer Narrative

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.Engineering verified that jaw alignment of device was within specifications.Engineering inspected jaws under a microscope and found no physical damage to the jaws.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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.

• 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: 7193965
• MDR Text Key: 97502410
• Report Number: 2647580-2018-00306
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000747
• UDI-Public: 20884523000747
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2018

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: 03/31/2022
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P7C1168X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 02/28/2018; 03/29/2018
• Supplement Dates FDA Received: 03/16/2018; 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2017
• 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
• Patient Age: 52 YR