MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; STAPLE, IMPLANTABLE

Model Number	HEM3348
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: hem3348 33mm haemorrhoid stap4.8mmstap (lot#: n2m0133y) 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 hemorrhoid case, the stapler did not fire.The surgeon used a new stapler from the same batch to complete the case.No tissue damage happened during the initial surgery.The next day, the patient had a bleeding.The patient was put on medication to treat the bleeding and was taken back to the operating room wherein multiple stitches were made to the staple line.Blood transfusion was not needed.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19707102
• Report Number: 1219930-2024-03130
• Device Sequence Number: 15391295
• Product Code: GDW
• UDI-Device Identifier: 10884521047563
• UDI-Public: 10884521047563
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: K083781
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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: HEM3348
• Device Catalogue Number: HEM3348
• Device Lot Number: N2M0133Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/09/2024
• Date Device Manufactured: 12/05/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 53 KG