MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ANGLED LOOP; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number	01985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  release date: august 2015.Expiry date: june 2020.Upon visual inspection, the tip shows signs of activation and the active loop is missing.The remainder of the device is in good condition.The condition of the electrode tip indicates that activation was stopped at the point of failure due to the sharp edges and surfaces of the fracture location.
Event or Problem Description
It was reported that the patient underwent myomectomy on (b)(6) 2017.During the procedure, it was reported that the handle broke after it was triggered.Upon device evaluation, the loop was found broken.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VERSAPOINT ANGLED LOOP
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7462236
• Report Number: 2210968-2018-72349
• Device Sequence Number: 1092483
• Product Code: HIH
• UDI-Device Identifier: 10705031001008
• UDI-Public: 10705031001008
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

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 Catalogue Number: 01985
• Device Lot Number: UGY1507234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1