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	12/05/2018
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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.It was reported the product broke.Please explain what part of the device broke and how did it brake? did the broken piece fall into the patient? was the broken piece retrieved? was there any patient consequence or any medical/surgical intervention and/or treatment rendered? will any of the product be returned for analysis?.
Event or Problem Description
It was reported that the patient underwent a hysteroscopy procedure on (b)(6) 2018 and the electrosurgical device was used.It was also reported that the device broke.There was no patient consequence reported.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 03/04/2019.Additional summary: the device has not been returned in its original packaging.The active tip is snapped and deformed.The device shaft has bend in the middle of the shaft.The device as presented appears to have seen a level of misuse to the shaft and the distal active tip is snapped in the centre position.It is not known how the damage to the shaft has occurred, it may have been due to shipping without protection.The condition of the fracture face of the active tip suggests a brittle failure with no obvious signs of mechanical damage.Instances of similar failures have been seen historically, with the failure location, mode and method indicating failure due to surface (hydrogen) embrittlement.Ifu advise the user not to operate the electrode in the beak of the sheath.Cause code: user / use error | wrong handling; user / use error | excessive force.

• 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: 8206085
• Report Number: 2210968-2018-78093
• Device Sequence Number: 13943216
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 01/31/2023
• Device Catalogue Number: 01985
• Device Lot Number: UGY1802009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 03/04/2019
• Patient Sequence Number: 1