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

Model Number	174309
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2020
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, prior to low anterior resection procedure, the shaft of the device came off.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the plastic cable sheath had shearing damage.A functional evaluation found that: jaws of device opened and closed without difficulty.Device rotated without difficulty.Dissecting jaws cut test media without difficulty.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 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.
Event or Problem Description
According to the reporter, prior to low anterior resection procedure, the sheath of the shaft came off.Another device was used to complete the case.There was no patient involvement.

• 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: 9953507
• Report Number: 2647580-2020-01316
• Device Sequence Number: 19389450
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: P4J0336X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1