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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
Model Number EPS03
Device Problems Electrode (451); Material Puncture/Hole (1504); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch #unk. As the device was not returned, an analysis investigation could not be performed. A conclusion could not be reached as to what may have caused or contributed to the event. The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

 
Event Description

It was reported that during a laparoscopic hysterectomy, the tip of the electrode came out from the hole on the shaft during use. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.

 
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Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
00969
Manufacturer Contact
kara ditty-bovard
475 calle c
guaynabo 00969
  00969
6107428552
MDR Report Key9687780
MDR Text Key196745577
Report Number3005075853-2020-00887
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
Reporter Occupation
Type of Report Initial
Report Date 01/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEPS03
Device Catalogue NumberEPS03
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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