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

Model Number	EEATAID25D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
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 a gastric bypass, the device snapped at the stem after being torqued upon entry into patient.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 06473
• MDR Report Key: 8923314
• Report Number: 1219930-2019-04855
• Device Sequence Number: 11314276
• Product Code: FZX
• UDI-Device Identifier: 20884521045719
• UDI-Public: 20884521045719
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 08/22/2019

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 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: 07/31/2019
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1