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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); Entrapment of Device (1212); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/25/2014
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional information: the analysis results found that the b12srt device was returned in good condition. In an attempt to replicate the reported incident, the device was functionally tested to detect any drag force issues. Upon evaluation of the device, a test er420 instrument was inserted and no issues were noted related to an abnormal drag force; in addition, the seals were in good condition. The device was fully functional according to the manufacturing requirements. No conclusion could be reached as to what may have caused the reported incident. 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.

 
Event Description

It was reported that during an unknown procedure, the doctor felt that a concomitant device was caught in the device when it was inserted into the patient. Then, it was found that the internal valve was out of alignment. Another device was used to complete the case. There were no adverse consequences to the patient.

 
Manufacturer Narrative

(b)(4). Information was not provided by the initial contact. Information is unavailable. 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.

 
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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 Key4419130
MDR Text Key12943025
Report Number3005075853-2015-00374
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 12/29/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12SRT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2015
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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