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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 B12SRT
Device Problems Valve(s) (527); Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unknown. The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed. Additional information requested and received: it was reported that the ¿valve¿ was broken off. Are you referring to the dark gray seal that the instruments pass through? yes.

 
Event Description

It was reported that during an unknown procedure, the valve was broken off during use, and the broken pieces fell into the patient. All fallen pieces were retrieved, and no pieces were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient.

 
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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 Key8704030
MDR Text Key149131521
Report Number3005075853-2019-19793
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 FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2019
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 Manufacturer06/27/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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