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	03/09/2018
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.Product release date: september 2017, product expiry date: july 2022.Attempts are being 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please confirm or clarify what occurred with the device, did the tip of the electrode break or break away or off from the electrode?.
Event or Problem Description
It was reported that the patient underwent cystectomy on (b)(6) 2018.During the procedure, the strap broke during use.It was reported that no part of the broken part fell into the patient.The procedure was completed with a like device.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Pc-(b)(4).Additional information was requested and the following was obtained: the electrode broke leaving only on one side, not detaching on the other side.With this, the doctor in charge concluded that no foreign body fell in the patient's abdominal cavity.
Additional Manufacturer Narrative
Summary: the device was received for evaluation.The active tip of the device was found to be broken, basic electrical testing was conducted, with no issues.Signs of usage were identified, resulting in a conclusion that the failure occurred during or after use.The failure location, mode and method do indicate failure due to surface (hydrogen) embrittlement.Cause: user/ user error/ wrong handling.

• 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: 7393447
• Report Number: 2210968-2018-71847
• Device Sequence Number: 1252345
• Product Code: HIH
• UDI-Device Identifier: 10705031001008
• UDI-Public: 10705031001008
• Combination Product (Y/N): N
• 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): 03/14/2018

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: UGY1708072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/05/2018; 08/02/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 04/06/2018; 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR