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

Model Number	176613
Medical Device Problem Codes	Entrapment of Device (1212); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, during the procedure, there were some notches on the tip of the retractor that they could not see with naked eyes but could be noticed on the monitor.The bowel was constantly getting caught in this, and that is abnormal.There was no patient injury.
Additional Manufacturer Narrative
Additional information: a1, a2, a3a, a4, b5, d9, d9 (return date), g3, h3, h6.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 robotic assisted myomectomy procedure, there were some notches on the tip of the retractor that they could not see with naked eyes but could be noticed on the monitor.The bowel was constantly getting caught in this, and that was abnormal.To resolve the issue, a grasper was used to removed the tissue.There was no patient injury.
Event or Problem Description
According to the reporter, during a robotic assisted myomectomy procedure, there were some notches on the tip of the retractor that they could not see with naked eyes but could be noticed on the monitor.The bowel was constantly getting caught in this, and that was abnormal.To resolve the issue, a grasper was used to remove the tissue.There was no patient injury.
Additional Manufacturer Narrative
Correction: b5, e4 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no abnormalities.Functionally, the fan was able to open and close without difficulty.The distal end of the fan noticed a gouge leaving a burr.It was reported that the device tip had some notches and the bowel was constantly getting caught on it.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This may occur if the device was exposed to an excessive or improper 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: device was contraindicated for certain applications.The device was to be disposed of properly.Product sale and use were restricted to surgeons and qualified individuals.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: 19817495
• Report Number: 2647580-2024-03217
• Device Sequence Number: 8665472
• Product Code: GAD
• UDI-Device Identifier: 10884523000849
• UDI-Public: 10884523000849
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2024

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: P2B0917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 09/04/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/13/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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 Age: 39 YR
• Patient Sex: Female
• Patient Weight: 82 KG