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	07/01/2019
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 general laparoscopic procedure, while cutting of tissue, the device sheers would not open.It was also noted that the device did not grasp properly.Another sheer was opened and the case continued without incident.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.No nicks were observed on the cutting edge of the jaws of the device.One jaw of the device was observed to be bent beyond the other side of the jaw.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 jaw of the device is subjected to excessive manipulation or leveraging forces which would result in deformation of the jaws, change in jaw configuration and/or jaw operating mechanisms.This damage would prevent the device from functioning properly.The root cause of the observed damage was due to the product not being used as intended 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: 8828040
• Report Number: 2647580-2019-03868
• Device Sequence Number: 14071256
• Product Code: GEI
• UDI-Device Identifier: 10884523000733
• UDI-Public: 10884523000733
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 04/30/2023
• Device Model Number: 176643
• Device Catalogue Number: 176643
• Device Lot Number: P8D1238X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1