MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO RETRACT; RETRACTOR

Model Number	176613
Medical Device Problem Codes	Difficult to Remove (1528); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during laparoscopic thoracic surgery, when the device was used, it was working well until, when the surgeon was trying to close the fan to pull it out, the fan would not close.To resolve the issue, the surgeon had to force the fan to close using an instrument so the surgeon could get it out of the port.There was no patient injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDO RETRACT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18955940
• Report Number: 2647580-2024-01322
• Device Sequence Number: 14597352
• Product Code: GAD
• UDI-Device Identifier: 10884523000849
• UDI-Public: 10884523000849
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K914190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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 Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P2G0345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male