MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO SHEARS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	176643
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, the device was used on the patient, the tip would not close.The device did not grasp properly.They discarded and opened another device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the jaws were returned open.Jaws were cleaned and inspected under a microscope.A nick was observed on the cutting edge of the jaws of the device.A functional evaluation found that the device jaws could not be closed, handle actuation was also impeded by jaws not closing.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur when the device is actuated over on obstruction, this results in damage to the cutting edge in the form of nicks.This damage could prevent the device from cutting or closing properly.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO SHEARS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8386162
• Report Number: 2647580-2019-01133
• Device Sequence Number: 2051914
• Product Code: GEI
• UDI-Device Identifier: 10884523000733
• UDI-Public: 10884523000733
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 176643
• Device Catalogue Number: 176643
• Device Lot Number: P8K1653Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1