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

Model Number	EEAORVIL21A
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: onb12stf - onb12stf versaone opt 12 std trocar, lot# unknown eeaxl2135 - eeaxl2135 eea xl 21mm-3.5 sgl use stap, lot# p4a0965.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 laparoscopic roux-en-y gastrectomy, upon initial access for the trocar, the trocar was leaking gas during the surgery when a 5mm instrument was inserted into it, but it did not leak when the 12mm stapler was inside the port.The surgical team had to cut both sutures connected to the tubing in order to get the tubing to release from the anvil.Also, a piece of the suture that was attached to the suture wheel was left in the staple line of the circular anastomosis.The device was retrieved by a gi scope with a guide wire that has a grasper at the distal tip of the wire.The surgeon kept using the trocar throughout the procedure.There was no patient injury. .
Additional Manufacturer Narrative
Additional information: g3, h3, h6 correction: b5 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was a component that disengaged and the orvil anvil was difficult to remove from tubing.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 laparoscopic roux-en-y gastrectomy, upon initial access for the trocar, the trocar was leaking gas during the surgery when a 5mm instrument was inserted into it, but it did not leak when the 12mm stapler was inside the port.The surgical team had to cut both sutures connected to the tubing in order to get the tubing to release from the anvil.Also, a piece of the suture that was attached to the suture wheel was left in the staple line of the circular anastomosis.The device was retrieved by a gi scope with a guide wire that has a grasper at the distal tip of the wire.The surgeon kept using the trocar throughout the procedure.

• Brand Name: EEA ORVIL
• 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: 19348459
• Report Number: 1219930-2024-02188
• Device Sequence Number: 7298937
• Product Code: GDW
• UDI-Device Identifier: 10884521042858
• UDI-Public: 10884521042858
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 07/31/2026
• Device Model Number: EEAORVIL21A
• Device Catalogue Number: EEAORVIL21A
• Device Lot Number: N3H2028Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/19/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 127 KG