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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number B12SRT
Device Problems Valve(s) (527); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Upon device analysis it was determined that the device was reprocessed so therefore it is no longer considered a reportable file. Third party re-processor is unknown. The analysis results found that the device was returned with the universal seal reprocessed and the protector found is not consistent with the protector utilized by ethicon endo. Upon visual inspection, the seals from the universal seal were found to be torn and wrinkly. In addition, the duckbill was observed to be out of the sleeve assembly. No further testing will be performed.

 
Event Description

It was reported that during a laparoscopic low anterior resection, the valve fell into the patient when a forceps with gauze was inserted via the trocar. The fallen valve was removed from the patient. Another device was used to complete the case. There were no adverse consequences to the patient.

 
Manufacturer Narrative

(b)(4). 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. At the time of this submission, the device has not been returned for analysis. Additional information was requested and the following was obtained: is fallen valve that was retrieved being sent back for analysis with rest of device? --- no information.

 
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Brand NameENDOPATH XCEL 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 Key4672339
MDR Text Key13384039
Report Number3005075853-2015-02242
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12SRT
Device LOT NumberM4H201
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/04/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

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