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

Model Number 00467

Device Problem Material Integrity Problem (2978)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device history: the results of this review indicate there were zero non-conformance's regarding the nature of the complaint associated with lot ugy1909131.Release date: october 2019.Expiry date: 23rd september 2023.Evaluation: visual inspection: device not returned in the original packaging.The active tip of the device showed no signs of activation.The active tip was bent.The device shaft was distorted.The active contact plate was distorted and no longer a tight on the connector.The active contact plate solder was fractured.Inspection revealed that the active contact plate was not secure on the connector and the solder connection had fractured.It's not clear how this failure occurred.One potential cause is if the solder connection breaks, when inserted the active contact plate is pushed forward over the insulation section of the connector, which then splays out the plate increasing the diameter and therefore making it a loose fit.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent a hysteroscopy on an unknown date in (b)(6) 2021 and the electrode was used.Prior to the procedure it was found that a piece of metal at the end of the electrode was not tight enough and unable to insert into the cable.Upon evaluation of the return sample it was found that a piece of the electrode had broken off.It was reported that the case was completed with another electrode.The event did not occur during sterile processing.The event did not occur during field inspection.There were no adverse patient consequences reported.

• Brand Name: VERSA TWIZZLE TIP
• 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; 9600 louisiana ave. north; brooklyn park MN 55445
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12005960
• MDR Text Key: 256779609
• Report Number: 2210968-2021-05562
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10705031000780
• UDI-Public: 10705031000780
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: 00467
• Device Catalogue Number: 467
• Device Lot Number: UGY1909131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1