MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO MINI-SHEARS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174309
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
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, post-operatively, the stapler did not fire.It was also reported that the surgical shears had no bite due to split joint.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 far beyond the other side of the jaw.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 found to be due to the device 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 MINI-SHEARS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8974877
• Report Number: 2647580-2019-04493
• Device Sequence Number: 16190257
• Product Code: GCJ
• UDI-Device Identifier: 10884523000689
• UDI-Public: 10884523000689
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K914752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: 09/01/2019
• Device Model Number: 174309
• Device Catalogue Number: 174309
• Device Lot Number: P4J0762X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1