MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*ULTRAVERES NDL 120MM; ENDOPATH INSUFFLATION NEEDLE

Catalog Number	UV120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: was the end of the needle bent or damaged in any way? yes.The tip of the veress needle was missing the rounded tip with the vent hole.It was just a straight edge at the tip.Was the needle blocked not allowing fluid to go thru? no.Did the needle not insufflate or maintain insufflation? i don't know.When the tip was discovered faulty, it's use was terminated.
Event or Problem Description
It was reported that during an unknown procedure that the tip was faulty.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4).Medical device: batch # 63772 device analysis: the analysis results found that six uv120 device were returned for analysis.Five were returned inside it's original package and one was received with no blunt safety stylet.In order to evaluate the condition of the internal components the device was disassembled; upon disassembling was confirmed that the needle sleeve was assembled the other way around with the blunt safety stylet inside the handle.No conclusion could be reached as to what may have caused the reported incident.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.

• Common Device Name: ENDOPATH INSUFFLATION NEEDLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7669352
• Report Number: 3005075853-2018-11166
• Device Sequence Number: 16532668
• Product Code: HIF
• UDI-Device Identifier: 20705036013423
• UDI-Public: 20705036013423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K983925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 03/31/2023
• Device Catalogue Number: UV120
• Device Lot Number: R40A9Z
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 07/30/2018
• Patient Sequence Number: 1