MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	B12XT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: please confirm if were there any patient consequences? if yes, please describe.
Event or Problem Description
It was reported that during an unknown procedure, after inserting the device into the trocar, it was noted the device was broken into a few pieces.All pieces were removed from the patient.Another device was used to complete the surgery.Patient consequence was not reported.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/3/2020.D4: batch #r9583u.Investigation summary the analysis results found that the b12xt device was received with the tip of the sleeve damaged.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.One possible cause for this type of damage is due to improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.H2: additional information was requested and the following was received: there was no patient consequence.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10045793
• Report Number: 3005075853-2020-02576
• Device Sequence Number: 16967214
• Product Code: GCJ
• UDI-Device Identifier: 10705036001195
• UDI-Public: 10705036001195
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 11/15/2023
• Device Model Number: B12XT
• Device Catalogue Number: B12XT
• Device Lot Number: T4004J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/05/2020
• Patient Sequence Number: 1
• Patient Age: 28 YR