MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111989
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open bowel resection, after firing, the stapler was removed and the anvil did not come with the device and was left behind in the bowel and were all retrieved using the surgeon's hand.The patient was scoped to check the anastomosis and donuts were removed to resolve the issue.It was noted that the anastomosis and donuts were intact and the donuts were removed.

• Brand Name: PREMIUM PLUS CEEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• MDR Report Key: 12345902
• Report Number: 3006451981-2021-00107
• Device Sequence Number: 4381427
• Product Code: GDW
• UDI-Device Identifier: 10884523006612
• UDI-Public: 10884523006612
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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 Expiration Date: 01/20/2024
• Device Model Number: 111989
• Device Catalogue Number: 111989
• Device Lot Number: S9AC006X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention