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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ENDOPATH TROCARS LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 23NBS
Device Problems Valve(s) (527); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2015
Event Type  Malfunction  
Event Description

It was reported that during a lap urological procedure, a valve was damaged and it was found that the damaged part was inside the housing. The device was used as-is 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.

 
Manufacturer Narrative

(b)(4). Additional information: the analysis results found that a 23nbs device was received with the outer gasket torn. Upon visual inspection with magnification, the outer gasket was confirmed to have evidence of cuts and a piece of the gasket was found to be inside the housing of the device; no missing parts. A possible cause for this damage is the use of sharp instruments during the procedure. Use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the gaskets 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. We did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check manufacturing records for any related non-conformances.

 
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Brand NameENDOPATH TROCARS
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 Key4606454
MDR Text Key5761087
Report Number3005075853-2015-01756
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK972578
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 02/26/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number23NBS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/31/2015
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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