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	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: was the broken piece of the loop retrieved from the patient? yes.What was the procedure being preformed? endometrial resection.Date of procedure? (b)(6) 2019.Was any medical/surgical intervention and/or treatment rendered? the procedure was completed with another device.
Event or Problem Description
It was reported that the patient underwent an endometrial resection on (b)(6) 2019.During the procedure, the loop fell off and was retrieved from the patient.A new loop was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Additional summary: the device has not been returned in its original packaging.Visual evaluation revealed that the active tip of the device is cracked in two places and the shaft of the device is slight twisted at the proximal end.No functional testing conducted due to the condition of the device.Closer inspection of the fracture surfaces of the electrode shows evidence of a brittle failure, with no evidence of failure due to a mechanical force.The failure location, mode and method indicate failure due to surface (hydrogen) embrittlement.The cause determined as user/use error or 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: 8344128
• Report Number: 2210968-2019-78911
• Device Sequence Number: 11271315
• Product Code: HIH
• UDI-Device Identifier: 10705031001008
• UDI-Public: 10705031001008
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 01/22/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 01985
• Device Lot Number: UGY1806094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 04/22/2019
• Patient Sequence Number: 1