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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 04/16/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

 
Event Description

It was reported that during a laparoscopic hysterectomy, the device was not activated. The first eph02 and the first eps03 were not used for the patient. Another eph02 and another eps03 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 Key7488376
MDR Text Key107455427
Report Number3005075853-2018-09578
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 04/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/04/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
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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