MAUDE Adverse Event Report: COVIDIEN SURGICAL EEA ORVIL; STAPLE, IMPLANTABLE

Model Number	EEAORVIL25A
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abdominal Pain (1685); Laceration(s) (1946)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 - concomitant product: trieeaxl25mt, cir stplr trieeaxl25mt medthk, (lot# p3h1251).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, intra-operatively of a total gastrectomy, during the anastomosis of the esophageal stump and the elevated jejunum, the circular stapler handle and the oral anvil could not be attached which resulted in the anastomosis being unable to be performed.The procedure was changed from laparoscopy to laparotomy and thoracotomy.The surgical time was extended for three hours.It was reported that the patient had acute abdominal pain post-operatively.
Additional Manufacturer Narrative
Additional information: d9, 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 orvil anvil was observed to be tilted and separated from the tubing.Further inspection of the orvil anvil cutting ring showed no traces of knife impression and the ring was received intact.One of the retainer legs of the orvil anvil was observed to be bent.It was reported that the circular stapler handle and the oral anvil could not be attached which resulted in the anastomosis being unable to be performed.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the orvil anvil is manipulated with excessive force during the attachment to the instrument, or if the orvil anvil is mishandled during the removal from the tubing.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: "do not grasp/clamp on the legs (open end) of the anvil/center rod assembly.Doing so could bend the legs and make it difficult to a ttach/detach the anvil to the integrated trocar of the stapler."".Orvil anvils are to be used with xl dst instruments and tri orvil anvils are to be used with tri eea instruments.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: EEA ORVIL
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24209820
• Report Number: 1219930-2026-00553
• Device Sequence Number: 21248177
• Product Code: GDW
• UDI-Device Identifier: 10884521042872
• UDI-Public: (01)10884521042872(17)270831(10)N4J1907Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: EEAORVIL25A
• Device Catalogue Number: EEAORVIL25A
• Device Lot Number: N4J1907Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 09/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male