MAUDE Adverse Event Report: COVIDIEN LP BARRX BEACON; KIT, NEEDLE, BIOPSY

Model Number	DSA-135-01
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
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, the device snapped in half during the procedure.The handle is broken seemed to have occurred on/around the time of the first pass attempting to enter the bile duct.After it broke, it was difficult to remove it from the scope and it seemed that a wrench was used.The customer had to change out the scope and switch to a different modality.It was verified by the sales representative that it was a broken handle and not a broken cannula tip.There was no patient and user harm.

• Brand Name: BEACON
• Common Device Name: KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 9942623
• Report Number: 3004904811-2020-00007
• Device Sequence Number: 3752769
• Product Code: FCG
• UDI-Device Identifier: 10884521663527
• UDI-Public: 10884521663527
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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: 08/06/2022
• Device Model Number: DSA-135-01
• Device Catalogue Number: DSA-135-01
• Device Lot Number: F2510861X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1