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)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r94a1l.Device analysis: the analysis results found that the b15lt device was returned with the seal damaged and torn; the torn piece of the seal was returned.The device was visually inspected in order to evaluate the condition of the seal and the damage was confirmed and the separate piece of the seal was observed to have a mark which suggests that a pointy instrument was inserted through the trocar with excessive force.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." a manufacturing record evaluation was performed for the finished device batch/lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a laparoscopic prostatectomy surgery, endopath xcel trocar universal seal was broken and one piece of this seal was found separately from the operation site.Dark gray leaflet on the inside of the universal seal become broken.This piece of seal was removed, and surgery continued in usual manner.There were no patient consequences.

• 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: 8464897
• Report Number: 3005075853-2019-17659
• Device Sequence Number: 1781212
• 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: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 07/31/2023
• Device Catalogue Number: B15LT
• Device Lot Number: R40X1G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/29/2019
• Patient Sequence Number: 1