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

Model Number	174309
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
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 procedure, white plastic cover was broken.Also the device did not grasp properly and the handles did not bind.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopy-assisted vaginal hysterectomy, white plastic cover, at the tip part, plastic area to prevent thermal damage, was broken.Also the device did not grasp properly and the handles did not bind.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of device.Shearing damage of the plastic cable sheath was observed.Engineering found that the condition of the device was consistent with a device that was subjected to mishandling during application.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 where an excessive force or leverage is applied to the device while retracting the clevis assembly and the clevis boot is subsequently damaged.This subsequent damage may result in improper retraction and deployment of the jaws during articulation and may cause shearing of the plastic cable sheath.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 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: 7910103
• Report Number: 2647580-2018-04707
• Device Sequence Number: 13789897
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2019

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: 06/30/2020
• Device Model Number: 174309
• Device Catalogue Number: 174309
• Device Lot Number: P5F0139X
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 03/18/2019
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/27/2018; 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1