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	Unintended Radiation Exposure (4565)
Date of Event	04/10/2025
Type of Reportable Event	Serious 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.
Event or Problem Description
According to the reporter, during a laparoscopic procedure involving membrane clamping, the tip of the device broke off and fell into the patient's abdominal cavity.All dislodged components were successfully retrieved through visual inspection and confirmed with an x-ray.A new product was used to resolve the issue.
Additional Manufacturer Narrative
Additional information: d4(expiration date, lot number and udi), d9, g3, h3, h4, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaws of the device were disengaged at the distal end.It was reported that there was a component that disengaged.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue can occur if the device was exposed to a side force (leverage) that consequently breaks one side of the jaws.Another possibility is when the device was activated with too much force to the jaws and was 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: the atraumatic jaws are clamped and locked onto tissue structures by closing the handles.The endo clinch¿ ii 5 mm instrument has a ratchet mechanism that can be switched on or off, for user¿s preference.To activate the ratchet mechanism slide the ratchet button forward towards the jaw.To deactivate the ratchet mechanism, slide the ratchet button back towards the handle.Place the instrument on the tissue and close the handle to the most appropriate position for the tissue thickness.To release the tissue or structure from the jaws, when the ratchet mechanism is activated, simply pull the release lever on the handle.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: 21900238
• Report Number: 2647580-2025-01310
• Device Sequence Number: 17165082
• Product Code: HDA
• UDI-Device Identifier: 10884523000832
• UDI-Public: (01)10884523000832(17)290630(10)P4G1233
• 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): 07/03/2025

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: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P4G1233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown