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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II SHAFT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number EPS03
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during a laparoscopic unknown procedure, the device was not activated from the beginning. Another eps03 and another eph02 were used to complete the case. There were no adverse consequences to the patient.

 
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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 Key7485560
MDR Text Key107453168
Report Number3005075853-2018-09548
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK912492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial
Report Date 04/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEPS03
Was Device Available For Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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