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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); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Date of event: unknown. Medical device: batch # r95245. Device analysis: the analysis results found that the b12srt device was returned with no damage in the external components. The device was visually inspected and no damaged was observed from the sealing components. The device was functionally tested to detect any mechanical issues. Upon evaluation of the device, no issues were noted related to a mechanical issues. No conclusion could be reached as to what may have caused the reported incident. The reported complaint could not be confirmed. A manufacturing record evaluation was performed for the finished device lot r41824 number, and no non-conformances were identified. A manufacturing record evaluation was performed for the finished device batch r95245 number, and no non-conformances were identified.

 
Event Description

It was reported that during an unknown procedure, the valve had a difficulty in closing (internal seal, valve inside of the trocar). 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 Key8649284
MDR Text Key146367583
Report Number3005075853-2019-19376
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
Report Date 05/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12SRT
Device LOT NumberR41824
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/27/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/23/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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