MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*XCEL DIL TIP TROC PAK; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	K5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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 lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, while inserting trocar for the first time, yellow shield got split.Surgeon was not able to remove trocar from sleeve.Had to use clamp to bend back yellow shield in order to remove it.There were no patient consequences.It is unknown if the procedure was delayed and how the procedure was completed.Lot is unknown.
Additional Manufacturer Narrative
(b)(4).Batch # r9573p.Device analysis: the analysis results found that the k5lt device was returned with the bullet damaged.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.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch r9573p number, and no non-conformances were identified.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8711756
• Report Number: 3005075853-2019-19859
• Device Sequence Number: 11263597
• Product Code: GCJ
• UDI-Device Identifier: 10705036002291
• UDI-Public: 10705036002291
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 11/30/2023
• Device Catalogue Number: K5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1