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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number B15LT
Device Problems Seal (432); Break (1069); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2019
Event Type  Malfunction  
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 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.

 
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Brand NameENDOPATH XCEL BLADELESS TROCAR
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer Contact
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key8464897
MDR Text Key140485101
Report Number3005075853-2019-17659
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB15LT
Device LOT NumberR40X1G
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/30/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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