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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 2/3 MM TROCAR 65MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. 2/3 MM TROCAR 65MM LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 23NBS
Device Problems Valve(s) (527); Break (1069); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed. 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.

 
Event Description

It was reported that during a laparoscopic unknown procedure, the outer seal of the valve fell off during use. The valve was broken outside the patient¿s body. No pieces were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient.

 
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Brand Name2/3 MM TROCAR 65MM
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
kara ditty-bovard
475 calle c
guaynabo 00969
6107428552
MDR Report Key9362809
MDR Text Key203521393
Report Number3005075853-2019-23702
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK972578
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 11/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number23NBS
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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