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

Model Number	174209
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
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 a laparoscopic duodenal switch, while using the device to dissect a window posteriorly on the duodenum near the pylorus the device fell apart.The extended tip fell into the patient when it broke apart but it was retrieved.Another device was opened to complete the case.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The instrument was received with the inner shaft disengaged from retraction slider; there was no sign of deformation or breakage.The knob component was inspected using a microscope and no indentation around the knob hole was observed.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.Improvements have been implemented to mitigate this condition.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: 8679392
• Report Number: 2647580-2019-02905
• Device Sequence Number: 13957328
• Product Code: GCJ
• UDI-Device Identifier: 10884523000801
• UDI-Public: 10884523000801
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K920068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 06/30/2023
• Device Model Number: 174209
• Device Catalogue Number: 174209
• Device Lot Number: P8F1564X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1