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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number H12LP
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). 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. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified. Additional information received: a photo was received for review. Upon visual inspection of the photo, the photo shows a totally dissembled trocar from front view. Based on the photo, the event described is confirmed. However, no conclusion or root cause could be determined as the device has not been received for analysis. Hands-on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

 
Event Description

It was reported that during a laparoscopic bilateral inguinal hernia procedure, everything had gone well in the surgery until the doctor tried to introduce a gauze through the trocar. It was disassembled and the trocar cleaning membranes detached and fell into the patient. The trocar was disarmed. There were no patient consequences reported.

 
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Brand NameENDOPATH XCEL BLUNT TIP 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
kara ditty-bovard
475 calle c
guaynabo 00969
6107428552
MDR Report Key10099470
MDR Text Key193314438
Report Number3005075853-2020-02747
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,Followup
Report Date 04/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH12LP
Device Catalogue NumberH12LP
Device LOT NumberU4009T
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/11/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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