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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 12X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 12X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 2CB12LT
Device Problems Valve(s) (527); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. A manufacturing record evaluation was performed for the finished device lot number t40k8l and no non-conformances were identified. 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 semi-open unknown procedure, the valve came off the sleeve during use, so the device could not be used. The surgeon removed all pieces without converting to laparotomy. Another device was used to complete the case. There were no adverse consequences to the patient.

 
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Brand NameOPT SLEEVE 12X100 STABILITY
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 Key9113950
MDR Text Key198884315
Report Number3005075853-2019-22316
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK122512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2CB12LT
Device LOT NumberT40K8L
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/24/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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