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

Catalog Number 00467

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The results of this batch review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.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.Additional information was requested, and the following was obtained: confirm that the devices were not used in a procedure or in a patient? they were not used in a procedure.It has been reported that the electrode packs cracks and the breaks always in the same place.Please provide the following: confirm that the rupture occurred in the primary packaging? yes.Does the "break" expose the electrodes, impacting sterility devices? yes.When the problem with packaging was noted for example was it prior to the devices entering the or after receipt of the devices by the dispenser? it was detected upon receipt of the device by the distributor.

Event Description

It was reported that prior to use of the electrosurgical/electrode device in the unknown procedure on the patient, the package was cracking; the rupture occurred in the primary packaging.As reported, this issue was never happened before.It was detected upon receipt of the device by the distributor.

Manufacturer Narrative

The results of the device history record for batch review indicate there were zero non-conformance regarding the nature of the complaint associated with this lot.The investigation showed that the returned blister had cracked as per customer claim.The overall condition of the blister is poor with the sealing surface being distorted and showing deformation.The active tip has impacted the blister wall which nearly penetrated through the blister.Once again, the blister had additional labels added to tyvek.Impact marks on the tyvek would suggest that the product has been incorrectly packed i.E.Blister against tyvek rather than tyvek against tyvek.In summary the results of the examination did not show any conclusive evidence as to why this failure occurred.The fracture region does not show any significant evidence of trauma, stress or impact damage and the exposed fracture surface did not show any obvious evidence such as defects, voids, embedded contamination as to help explain how the failure occurred.Fully assembled and sterilized twizzle blister was manipulated by hands, however the cracks observed did not represent the complaint device.In laboratory, it was attempted to ¿fail¿ the reference blister pack by manually bending and twisting by hand, which did not result in failure or micro-cracking.The situation observed does not represent what the situation would be in a fully assembled pack, however it did show that there is no significant evidence of ¿brittleness¿ in the blister pack at this stage in the process.Based on the evidence/findings provided it can be concluded that no material or process faults were found at which could be attributed to the failure seen.Cause code: undeterminable/unable to determine.

Manufacturer Narrative

Date sent to the fda: 07/24/2019.Corrected h-6 device codes: 2385.

• Brand Name: VERSA TWIZZLE TIP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8823999
• MDR Text Key: 152201758
• Report Number: 2210968-2019-84618
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10705031000780
• UDI-Public: 10705031000780
• Combination Product (y/n): N
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 00467
• Device Lot Number: UGY1809030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Date Manufacturer Received: 11/12/2019
• Patient Sequence Number: 1