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

Model Number 01985

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The device was not returned in the original packaging.The distal end shows no evidence of activation.There is visible burning/melting on the insulation between the active/return on the connector.No damage visible on cable or connector.The connector cable was not returned.A spare connector cable from product evaluation stock was used to conduct the functional testing.The device was connected to versapoint ii generator gml 4045/1.It was claimed the device did not work during the procedure.Visual inspection highlighted that the device was in a good condition but it was noted that the insulation section between the active and return on the connector did show slight burning/melting.This can occur if the device or cable connector is wet when assembled together, which can lead to activation in this area.Even with this visual damage the device successfully passed the electrical and functional tests without issue.It should be noted that a connector cable from pe stock was used for the testing as the end user connector cable was not returned with the device.(b)(4).The device history record for batch referenced above was reviewed for non-conformances related to the nature of the complaint during the manufacturing process.The results of this review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.Product release date: february 2020.Product expiry date: january 2025.

Event Description

It was reported that a patient underwent an unknown electrosurgical gynecological procedure on (b)(6) 2020 and the device did not work.No further event details were provided.

• Brand Name: VERSAPOINT ANGLED LOOP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff ; UK
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11812448
• MDR Text Key: 250399966
• Report Number: 2210968-2021-04495
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10705031001008
• UDI-Public: 10705031001008
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01985
• Device Catalogue Number: 01985
• Device Lot Number: UGY2001084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1