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

Catalog Number	B11LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.Additional information requested and received: please clarify: was the obturator damaged? or was the sleeve, cannula damaged? it was from cannula tip.
Event or Problem Description
It was reported that the trocar outer had a scratch (01.Mm).
Additional Manufacturer Narrative
(b)(4).Batch # m91440.Investigation summary: the analysis results found that the b11lt device was returned with no damage in the external components.The device was visually inspected, no damaged was found on the sleeve or missing pieces were observed from the sealing components.Upon evaluation of the device, it was functionally leak tested and passed.The device was fully functional according to the manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7935691
• Report Number: 3005075853-2018-13233
• Device Sequence Number: 2305642
• Product Code: GCJ
• UDI-Device Identifier: 10705036001126
• UDI-Public: 10705036001126
• 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): 09/06/2018

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: 03/31/2020
• Device Catalogue Number: B11LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1