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	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent hysteroscopy on (b)(6) 2018.During the procedure, the strap broke in the middle of the procedure.A similar product was used during the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Product release date: (b)(4) 2015.Product expiry date: (b)(4) 2020.
Additional Manufacturer Narrative
(b)(4).It is possible that there is a defect within the tip wire used to produce the active tip that could lead to a surface embrittlement failure.It should be noted that there is no sign of mechanical force or stress in the area of the tip failure.The remainder of the device was in good condition.The probable causes of the brittle fracture failure was the activation of the electrode in the beak of the sheath during use.

• 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: 7339782
• Report Number: 2210968-2018-71446
• Device Sequence Number: 163258
• 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,Followup,Followup
• Report Date (Section B): 02/16/2018

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: UGY1511072
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/20/2018; 04/26/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 03/23/2018; 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1