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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 Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.As a lot/batch was not provided, a device history could not be performed.
 
Event Description
Trocar couldn´t break through.Rubber seal not pierced.There were no consequences for the patient.
 
Manufacturer Narrative
(b)(4).Batch # r93m19.The analysis results found that the 2b12lt device was returned with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.During testing, they attempted to introduce the obturator into the sleeve assembly, however it could not be introduced due to a closed duckbill.This condition is most likely related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s, or protocols related to the complaint were found during the manufacturing process.
 
Manufacturer Narrative
(b)(4).Batch # r93m19.The analysis results found that the 2b12lt device was returned with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.During testing, they attempted to introduce the obturator into the sleeve assembly, however it could not be introduced due to a closed duckbill.This condition is most likely related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s, or protocols related to the complaint were found during the manufacturing process.
 
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Brand Name
OPT BLADELESS 12X100 STABILITY
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7983552
MDR Text Key124558412
Report Number3005075853-2018-13749
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036014218
UDI-Public10705036014218
Combination Product (y/n)N
PMA/PMN Number
K122512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue Number2B12LT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2018
Initial Date Manufacturer Received 10/02/2018
Initial Date FDA Received10/19/2018
Supplement Dates Manufacturer Received10/24/2018
Supplement Dates FDA Received11/14/2018
Patient Sequence Number1
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