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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
Model Number B11LT
Device Problems Break (1069); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # t92p0r. Date of event is unknown. Investigation summary: the analysis results found that the b11lt device was received with the tip of the sleeve melted. The obturator was returned with no apparent damage. The event described could not be confirmed as the clear lens was noted without damage. One possible cause for this type of damage may be interaction with an energized device used during the procedure. Caution should be taken to avoid contact between an energized device and the trocar during the surgical procedure. It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment. A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

 
Event Description

It was reported that during an unknown procedure, the product showed factory damage as the tip was broken. It is unknown how the procedure was completed. Patient consequence was not reported.

 
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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
00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
00969
Manufacturer Contact
kara ditty-bovard
475 calle c
guaynabo 00969
  00969
6107428552
MDR Report Key9886421
MDR Text Key200282347
Report Number3005075853-2020-01812
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 COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/26/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB11LT
Device Catalogue NumberB11LT
Device LOT NumberT4047N
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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