MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; GUIDE, SURGICAL, INSTRUMENT

Model Number	EEATAID25D
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product is not sold in us and is 510(k) exempt.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic robotic gastric bypass, the introducer was used before the circular stapler mated to the oral anvil, when grabbing the introducer to remove from the patient it was noticed that the the instrument actually split into 2 pieces.The doctor was able to remove the remaining piece of the introducer out of the patient's abdomen with a pair of graspers and the same oral anvil and stapler was used to resolve the issue.There was no patient injury.

• Brand Name: EEA
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12012486
• Report Number: 1219930-2021-02398
• Device Sequence Number: 4600672
• Product Code: FZX
• UDI-Device Identifier: 20884521045719
• UDI-Public: 20884521045719
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 10/31/2022
• Device Model Number: EEATAID25D
• Device Catalogue Number: EEATAID25D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1