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 Codes	Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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 laparoscopic hepatectomy procedure, the tip of the device did not connect with handle.The device was remove from the cavity with the trocar.The patient had an infection so the device will not be returned.The procedure was completed with another device.There was no patient injury.

• 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: 7654306
• Report Number: 2647580-2018-03255
• Device Sequence Number: 16173545
• Product Code: GCJ
• UDI-Device Identifier: 20884523000808
• UDI-Public: 20884523000808
• 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
• Report Date (Section B): 07/02/2018

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: 09/30/2022
• Device Model Number: 174209
• Device Catalogue Number: 174209
• Device Lot Number: P7J0929X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1