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	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a hysteroscopy on (b)(6) 2019 and the electrosurgical device was used.It was also reported that hand loop broke during the surgical procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 04/29/2019.Summary: the device has not been returned for evaluation in its original packaging and has been used.The device as presented clearly shows that the arms of the active tip electrode have snapped at the point where the loop goes into the vertical bend.The condition of the fracture face of the active tip suggests a brittle failure with no obvious signs of mechanical damage or reduction in cross-sectional diameter.The loop has also been eroded behind the fracture face.Instances of similar failures have been seen historically, with the failure location, mode and method indicating failure due to surface (hydrogen) embrittlement.Ifu advising the user not to operate the electrode in the beak of the sheath.

• 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: 8359872
• Report Number: 2210968-2019-78997
• Device Sequence Number: 19404472
• 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
• Report Date (Section B): 01/31/2019

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: 12/31/2022
• Device Catalogue Number: 01985
• Device Lot Number: UGY1801229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1