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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X75MM STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

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ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X75MM STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 2CB5ST
Device Problems Valve(s) (527); Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Investigation summary the analysis results found that the 2cb5st device was returned with no damage in the external components. The valve opened and closed without any difficulties. No conclusion could be reached as to what may have caused the reported incident. The reported complaint could not be confirmed. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.

 
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 an unknown procedure, the valve was broken off. No pieces fell into the patient. 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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Brand NameOPT SLEEVE 5X75MM 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
kara ditty-bovard
475 calle c
guaynabo 00969
6107428552
MDR Report Key9339510
MDR Text Key189669335
Report Number3005075853-2019-23578
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK032676
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 10/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2CB5ST
Device LOT NumberT40R1X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/26/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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