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

Model Number	174209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
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 laparoscopic hepatectomy procedure, when the package was opened, the black part at the tip of the retractor came off, and the product was unable to be used.The surgeon then used another device to resolve the issue in order 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 clevis fixture was broken and returned without the back tip of the blade.A functional evaluation found that the device articulated properly and 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.Ponce facility, without the broken tip provided for further evaluation of any damage, was unable to reliable determine the most probable root cause of the reported condition.Given all the controls in place, the most probable root cause is not manufacturing or material related.Replication of the reported condition may occur because of the instrument being forced beyond its indicated use due to applying excessive stress over the clevis.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO MINI-RETRACT
• 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: 8704597
• Report Number: 2647580-2019-03077
• Device Sequence Number: 1876418
• Product Code: GCJ
• UDI-Device Identifier: 10884523000801
• UDI-Public: 10884523000801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K920068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2019

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: 05/31/2023
• Device Model Number: 174209
• Device Catalogue Number: 174209
• Device Lot Number: P8E1407X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 08/15/2019; 09/19/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 09/09/2019; 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1