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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 75 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE

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ETHICON ENDO-SURGERY, LLC. 75 MM NTLC SELECTABLE RELOAD; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number SR75
Device Problems Failure to Advance (2524); Firing Problem (4011)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Month and day unknown.Only year (2018) is known.Batch # r58t7j.Device evaluation summary: the analysis found that one sr75 reload was returned with the knife exposed and the proximal 2 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position.The cartridge reload swing tab was reset in order to fire the cartridge.The cartridge was tested for functionality with a test device and fired without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper shape.A probable cause for the reported incident is the device may have been partially fired causing the lockout to be set.Reference ¿instructions for use¿ for complete firing instructions.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
 
Event Description
It was reported that in the course of a right hemi-"coloectomy" procedure using the ntlc, an error occurred in the process of firing.The blade suddenly stopped in the middle of the device, and the blade didn't move forward.As an emergency measure, the surgeon backed off the firing knob and detach it from the tissue.He changed a new cartridge and finished the procedure.There were no reported adverse consequences for the patient so far.
 
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Brand Name
75 MM NTLC SELECTABLE RELOAD
Type of Device
STAPLE, IMPLANTABLE
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 Key8275506
MDR Text Key134093062
Report Number3005075853-2019-16133
Device Sequence Number1
Product Code GDW
UDI-Device Identifier10705036002833
UDI-Public10705036002833
Combination Product (y/n)N
PMA/PMN Number
K092577
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/18/2018
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 Date06/11/2023
Device Catalogue NumberSR75
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2019
Initial Date Manufacturer Received 01/22/2019
Initial Date FDA Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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