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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 Break (1069); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). See facility medwatch number (b)(4). Additional information was requested and the following information was received: how was the procedure completed? torn off piece was retrieved and procedure completed in the normal manner. (b)(4).

 
Event Description

See user facility medwatch number: (b)(4).

 
Manufacturer Narrative

(b)(4). Batch # t93932. Investigation summary the analysis results found that the b15lt device was received with no apparent damage. In addition, a piece plastic was returned inside of a plastic bag. Further analysis the piece of plastic belongs to the duckbill. The tyvek was also returned along with the instrument. A leak test was performed, and the device was noted to leak without the test probe inserted through the device. No conclusion could be reached as to what might have caused the reported event. The reported complaint was confirmed. A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

 
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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 Key8997485
MDR Text Key163311369
Report Number3005075853-2019-21916
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 OTHER,USER FACILITY
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue NumberB15LT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/16/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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