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

Catalog Number	00467
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and the electrosurgical device was used.It was detected that the product packaging is cracking easily.There were no patient consequences reported.
Additional Manufacturer Narrative
A dhr has been performed during investigation stage for the complaint lot ugy1806015 and no issues or deviations with the manufacturing process have been indicated.Additional device evaluated by mfr summary: two blisters were returned for analysis and have been cracked as per the customer claim.The associated paper work with the product reads as if the damage as occurred/spotted at a distributor rather than end user.Both blisters have cracked in the central blister pocket.The one blister has two cracks, the other has one crack.The twizzle device in the one blister has dislodged from its retention channel and the active tip has been become bent.There is impact damage visible on the one corner of one of the pockets.The second blister shows creasing on one of the pockets, which was replicated during the investigation by bending the blister.A further pocket of the blister shows impact damage on one of the corners.Both blisters have had additional adhesive labels added to the tyvek post manufacture, suggesting the product would have been removed from the shelf carton and maybe repacked.Manipulation of sample blisters replicated the creasing in the pocket, the connector housing becoming dislodged and the tip hitting the underside of the blister.The testing did not replicate the cracking, it was found that the blisters only deformed.Conclusion: undetermined/ unable to determine.Note: due to both blisters were analyzed together and it is difficult to separate their evaluations, this medwatch 2210968-2019-84254 corresponds to first blister and related medwatch corresponds to second blister.

• Brand Name: VERSA TWIZZLE TIP
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8787372
• Report Number: 2210968-2019-84255
• Device Sequence Number: 1925662
• Product Code: HIH
• UDI-Device Identifier: 10705031000780
• UDI-Public: 10705031000780
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 05/31/2023
• Device Catalogue Number: 00467
• Device Lot Number: UGY1806015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 07/13/2019
• Supplement Report FDA Received Date: 11/18/2019
• Patient Sequence Number: 1