MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO CLINCH II; FORCEPS, OBSTETRICAL

Model Number	174317
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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
It was reported that during a laparoscopic cholecystectomy, when the handle was squeezed to insert it into the abdominal cavity from the trocar after opening, the device was disassembled like a collected product.Another device was used to complete the case.No parts fell into the patient's cavity.There was no patient injury.
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 that the device was received completely dismantled.Functional testing was not performed due to the devices returned condition.It was reported that the device component was disengaged.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 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.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.Consult the medical literature relative to complications, hazards and techniques, prior to performing endoscopic procedures.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 CLINCH II
• Common Device Name: FORCEPS, OBSTETRICAL
• 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: 21560914
• Report Number: 2647580-2025-00763
• Device Sequence Number: 18434361
• Product Code: HDA
• UDI-Device Identifier: 10884523000832
• UDI-Public: 10884523000832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903205
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P3K1385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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
• Patient Sex: Unknown