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

Catalog Number	B15LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).See facility medwatch number (b)(4).Additional information was requested and the following information was received: how was the procedure completed? torn off piece was retrieved and procedure completed in the normal manner.(b)(4).
Event or Problem Description
See user facility medwatch number: (b)(4).
Additional Manufacturer Narrative
(b)(4).Batch # t93932.Investigation summary the analysis results found that the b15lt device was received with no apparent damage.In addition, a piece plastic was returned inside of a plastic bag.Further analysis the piece of plastic belongs to the duckbill.The tyvek was also returned along with the instrument.A leak test was performed, and the device was noted to leak without the test probe inserted through the device.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

• 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: 8997485
• Report Number: 3005075853-2019-21916
• Device Sequence Number: 11352917
• Product Code: GCJ
• UDI-Device Identifier: 10705036001201
• UDI-Public: 10705036001201
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: B15LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1
• Patient Age: 63 YR