MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ANGLED LOOP; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	01985
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).The results of this review indicate there were zero non-conformance's regarding the nature of the complaint associated with this lot.Attempts are being made to receive a device for evaluation.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 hysteroscopic video myomectomy on (b)(6) 2019 and the electrosurgical device was used.It was reported that the bipolar loop broke due to the large myoma being hardened/calcified before complete resection.It was necessary to use another like loop to finish the myomectomy.The procedure was completed successfully.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 11/23/2020.Additional information: d9, h3, h6.H3 analysis summary: the active tip of the device has fractured from the distal tip.The condition of the fracture face of the device suggests a brittle failure with no obvious signs of mechanical damage.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• MDR Report Key: 9792445
• Report Number: 2210968-2020-01757
• Device Sequence Number: 11406728
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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 Model Number: 01985
• Device Catalogue Number: 01985
• Device Lot Number: UGY1802009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1
• Patient Age: 41 YR