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 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to being utilized in a laparoscopic case, the dissector was misaligned and was set aside.They used another dissector to complete the case.There was no patient injury.

Manufacturer Narrative

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: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7323732
• MDR Text Key: 101911496
• Report Number: 2647580-2018-01258
• Device Sequence Number: 1
• Product Code: GET
• UDI-Device Identifier: 20884523000747
• UDI-Public: 20884523000747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

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: 10/31/2022
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P7K1585X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 04/16/2018; 04/30/2018
• Supplement Dates FDA Received: 04/25/2018; 05/29/2018
• Date Device Manufactured: 10/26/2017
• 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