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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 B12LT
Device Problems Seal (432); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. 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. The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

 
Event Description

Duck seal damaged. During the endoscopic rectal cancer surgery, could not insert the obturator into the obturator sleeve. Checked the device, found the duck seal was not separated. Another device was used to complete the surgery. 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 Key7586888
MDR Text Key110910605
Report Number3005075853-2018-10476
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,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12LT
Device LOT NumberR4061H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/15/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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