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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number 2B5LT
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
 
Event Description
It was reported that during an unknown procedure the shaft of the trocar appeared to be bent and it was difficult to pull the device through the cannula.It was unknown how the procedure was completed.
 
Manufacturer Narrative
(b)(4).It was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.
 
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Brand Name
OPT BLADELESS 5X100 STABILITY
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7293178
MDR Text Key101010384
Report Number3005075853-2018-08170
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier20705036013706
UDI-Public20705036013706
Combination Product (y/n)N
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Catalogue Number2B5LT
Device Lot NumberP4TA9K
Was Device Available for Evaluation? No
Date Manufacturer Received03/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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