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

Model Number	173046
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Liver Laceration(s) (1955)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a laparoscopic adrenalectomy procedure, the surgeon discovered rifts on the liver upon insertion due to the sharpness of the broken/cracked tube side, which had a 5 cm crack in the paddle.The incision was extended due to device issue.There was an anticipated tissue loss as a result of the event.To resolve the issue, the procedure was converted to an open one, and the surgeon decided to withdraw the paddle and address the rifts by suturing.
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.
Additional Manufacturer Narrative
Additional information: b5, d9, g3.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.
Event or Problem Description
According to the reporter, during a laparoscopic adrenalectomy procedure, the surgeon discovered rifts on the liver upon insertion due to the sharpness of the broken/cracked tube side, which had a 5 cm crack in the paddle.The incision was extended due to device issue.There was an anticipated tissue loss as a result of the event.The procedure was prolonged/extended due to this device issue.To resolve the issue, the procedure was converted to an open one, and the surgeon decided to withdraw the paddle and address the rifts by suturing.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the inner shaft of the device was bent.It was reported that the instrument broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the device was leveraged and exposed to an improper or excessive force.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: the device is contraindicated for certain application and is to be disposed of properly.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 PADDLE 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: 19207183
• Report Number: 2647580-2024-01920
• Device Sequence Number: 7927568
• Product Code: GAD
• UDI-Device Identifier: 10884523000771
• UDI-Public: 10884523000771
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 173046
• Device Catalogue Number: 173046
• Device Lot Number: P3H1069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/06/2024; 06/21/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 05/09/2024; 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female