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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 12X100 STABILITY LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 2B12LT
Device Problems Seal (432); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unknown. 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. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.

 
Event Description

It was reported that during a laparoscopic colectomy, the outer seal came off the sleeve during use, and it could not be attached to the sleeve again. 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 BLADELESS 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 Key8703432
MDR Text Key148549890
Report Number3005075853-2019-19776
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 FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number2B12LT
Device LOT NumberT4073E
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/11/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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