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

Model Number	111989
Medical Device Problem Codes	Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Date of Event	08/25/2021
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 low anterior bowel resection, the first stapler was found pre-fired (the staples were already exposed) when the shipping wedge was removed.While the second device was able to fire, however, the staple line was incomplete resulting to an incomplete anastomosis.The surgeon had to tear the anastomosis down due to leakage before the protective ileostomy was created.The incomplete staple line was oversewn by the surgeon.When the stapler was removed from patient, the anvil disengaged.An xray was done to locate the component.The disconnected anvil was retrieved using a grasper utilizing a sigmoidoscope.The surgical time and hospitalization were both prolonged.

• 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: 12642453
• Report Number: 3006451981-2021-00135
• Device Sequence Number: 11113300
• Product Code: GDW
• UDI-Device Identifier: 10884523006612
• UDI-Public: 10884523006612
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K001895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 03/23/2024
• Device Model Number: 111989
• Device Catalogue Number: 111989
• Device Lot Number: S9CC012X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/15/2021
• 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