MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO DISSECT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number	176645
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy, when dissecting the free omentum, the tip of the four devices were not fully closed.The user opened another device with a different lot number to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: 176645, 176645 endo dissect 254 (lot#p4d1214); 176645, 176645 endo dissect 254 (lot#p4a0946); 176645, 176645 endo dissect 254 (lot#p4a0946) 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and four photos were available for evaluation.Functional testing found that the instrument was applied to test media.The jaws opened and closed without difficulty however there was a slight gap due to the misalignment.It was reported that the tip of the four devices were not fully closed.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue of the misaligned jaws may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage.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: endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.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 DISSECT
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• 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: 20604796
• Report Number: 2647580-2024-04643
• Device Sequence Number: 12596823
• Product Code: GET
• UDI-Device Identifier: 10884523000740
• UDI-Public: 10884523000740
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K904578
• 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
• Report Date (Section B): 01/20/2025

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: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P4D1214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: Unknown