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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number D11LT
Device Problems Valve(s) (527); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

 
Event Description

It was reported that during a lap chole procedure, the trocar came with a bent valve. It is unknown how the procedure was completed. Patient consequence was not reported.

 
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Brand NameXCEL DILATING TIP TROCAR 11MM
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
kara ditty-bovard
475 calle c
guaynabo 00969
6107428552
MDR Report Key9547581
MDR Text Key188495500
Report Number3005075853-2020-00063
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberD11LT
Device LOT NumberT4097R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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