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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 B12LT
Device Problems Valve(s) (527); Break (1069)
Patient Problem Foreign body, removal of (2365)
Event Date 12/15/2014
Event Type  Malfunction  
Event Description

It was reported that during a laparoscopic sigmoidectomy, a black rubber piece was found inside the patient and it was removed from the patient. Then, it was found that inside of the valve was damaged. It was confirmed that the rubber piece fitted with the damaged part. Another device was used to complete the case. There were no adverse consequences to the patient.

 
Manufacturer Narrative

(b)(4). Device not returned for analysis. Should the information be provided later, a supplemental medwatch will be sent.

 
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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 PR 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key4512890
MDR Text Key5408079
Report Number3005075853-2015-01053
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12LT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Initial

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