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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number TLH60
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/22/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.Additional information was requested and the following was obtained: did the device lock out and could not be fired at all? or was the trigger advanced with no staples deployed? the stapler fired without lock out and didn¿t' apply clips.The reload was properly placed.
 
Event or Problem Description
It was reported that during an unknown procedure, the device didn't apply the clips.The reload was replaced the issue was solved.There were no patient consequences reported.
 
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Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7337500
Report Number3005075853-2018-08526
Device Sequence Number172864
Product Code GDW
UDI-Device Identifier20705036013232
UDI-Public20705036013232
Combination Product (Y/N)N
PMA/510(K) Number
K020779
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/26/2018
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
Operator of Device Health Professional
Device Expiration Date10/31/2021
Device Catalogue NumberTLH60
Device Lot NumberN4M89T
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/26/2018
Initial Report FDA Received Date03/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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