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	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional summary: the device has not been returned in its original packaging for evaluation.The active tip on the returned device was found to be broken.The failure location, mode and method indicate failure due to surface (hydrogen) embrittlement.Ifu advising the user not to operate the electrode in the beak of the sheath.Cause: user / use error | wrong handling; user / use error | excessive force the review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.
Event or Problem Description
It was reported that the patient underwent a hysteroscopy procedure on (b)(6) 2018 and the electrosurgical device was used.There were no patient consequences reported.Another like device was used.During the evaluation, the active tip on the returned device was found to be broken.

• 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: 8251660
• Report Number: 2210968-2019-78432
• Device Sequence Number: 2418339
• 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): 12/20/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 01985
• Device Lot Number: UGY1711085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/16/2019
• Patient Sequence Number: 1