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	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The results of this review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.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 following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that the device "split".Do you mean that the tip of the device broke off? when did the split occur? did the device enter the patients cavity? if yes, please provide the following: was the device retrieved in its entirety? is all the components being returned for investigation? confirm no portion of the device was retained in the patients cavity.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the electrosurgical device was used.During the procedure, loop split.The procedure completed with another like device.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Additional h-3 summary: the device has not been returned in its original packaging for evaluation.The device has been used, as indicated by residuals remaining on loop arms.The active tip has snapped and deformed.The device as presented clearly shows the active tip had broken into two pieces.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.Instances of similar failures have been seen historically, with the failure location, mode and method indicating failure due to surface (hydrogen) embrittlement.Conclusion: user / use 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: 8733378
• Report Number: 2210968-2019-83274
• Device Sequence Number: 11406122
• Product Code: HIH
• UDI-Device Identifier: 10705031001008
• UDI-Public: 10705031001008
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 04/30/2023
• Device Catalogue Number: 01985
• Device Lot Number: UGY1805040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1