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

Catalog Number	B5XT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and to retrieve the device: were there any patient consequences? if yes, please describe.To date, no response or device has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, the trocar head was detached from cannula.Procedure was successfully completed.Patient consequence was not reported.
Additional Manufacturer Narrative
(b)(4).If follow-up, what type: additional information received: it was confirmed the only delay in procedure was to replace the device, there was no patient consequence, and the device was discarded by the account and therefore cannot be returned for analysis.
Additional Manufacturer Narrative
(b)(4).Per photographic evaluation: upon visual inspection of photo, the following was observed: the first, third and four photo show paperwork of device.The second photo shows a trocar with the cap of the sleeve slightly detached from the obturator.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/14/2020.H2: additional information received: "the device was discarded for contamination reasons and there were no patient consequences, just delay in the surgery due to replacing of device.".

• 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: 8809531
• Report Number: 3005075853-2019-20567
• Device Sequence Number: 2576104
• Product Code: GCJ
• UDI-Device Identifier: 10705036001249
• UDI-Public: 10705036001249
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2019

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: 08/31/2023
• Device Catalogue Number: B5XT
• Device Lot Number: R40Z89
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 12/18/2019; 12/18/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 07/26/2019; 12/18/2019; 01/14/2020
• Patient Sequence Number: 1