MAUDE Adverse Event Report: ETHICON INC. VERSA SPRING TIP; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	00468
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.To date the device has not been returned.A photo of the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and the electrode was used.During surgery, the electrode head broke.A like device was used to complete the surgery.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/09/2022.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, 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.The device history record 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 05/12/2022.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, 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.H3 evaluation: visual inspection: device not returned in the original packaging.The active tip shows no obvious signs of activation.The spring tip is bent to nearly.90° to the shaft but remains intact.The device shaft is slightly deformed.The returned electrode has not been returned with the connector cable.For a full evaluation, a spare connector cable from product evaluation (p.E) stock will be used.A spare connector cable was inserted into the versapoint 1 generator (gml1180/5), then the returned device inserted into the connector cable.The device was immediately recognized by the generator, with the correct default settings being displayed.Visual inspection recorded that the spring tip was still in one piece but was bent nearly 90° to the shaft.There was no evidence to explain why this had occurred.The device had not been returned in the original package and there was no clear evidence that the device had been activated.The device shaft was slightly deformed but it is not known if this occurred during use or transport.The device still successfully passed both functional and electrical tests.It should be noted that a connector cable from pe stock was utilized for the testing.

• Brand Name: VERSA SPRING TIP
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; 7 fortran road; st mellons CF30L T; UK CF30LT
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13321283
• Report Number: 2210968-2022-00570
• Device Sequence Number: 5113242
• Product Code: HIH
• UDI-Device Identifier: 10705031000797
• UDI-Public: 10705031000797
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: 06/04/2025
• Device Model Number: 00468
• Device Catalogue Number: 468
• Device Lot Number: UGY2006017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 04/12/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/09/2022; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown