MAUDE Adverse Event Report: ETHICON INC. ELECTRODE TORSADEE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 00467

Device Problem Material Integrity Problem (2978)

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

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Analysis summary: the active tip of the device shows no signs of activation.The active tip is bent 90° to the shaft and the device shaft is distorted.As the product was not returned in its original packaging we are unable to determine where the damage to the tip occurred.It is possible that the original packaging has become bent in some way, causing the device tip to come into contact with the hard surface of the blister wall causing it o be bent out of shape.Without the original packaging however this contact be confirmed or dismissed.There is insufficient data collected to determine the root cause of this failure.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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 an unknown gynecological procedure on (b)(6) 2020 and an electrode was used.It was reported that at the opening there was a bent hook.There were no adverse patient consequences reported.

• Brand Name: ELECTRODE TORSADEE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff ; UK
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 10969345
• MDR Text Key: 227893538
• Report Number: 2210968-2020-09703
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10705031000780
• UDI-Public: 10705031000780
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00467
• Device Catalogue Number: 00467
• Device Lot Number: UGY1909083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1