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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR CUTTER THICK; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR CUTTER THICK; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number TCT75
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/23/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being 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.
 
Event or Problem Description
It was reported that during a knee surgery, there was something wrong with the staples, misshapen.This caused issues with the tissue being resected.Surgeon chose to use another product to complete surgery.There was not a patient injury.The understanding was that the stapler misfired and that the staples were malformed, but there was not an injury.Some of the staples that come out of the device were saved and they are with the stapler.There were no patient consequences.
 
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Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key9120277
Report Number3005075853-2019-22334
Device Sequence Number14080831
Product Code GDW
UDI-Device Identifier10705036013150
UDI-Public10705036013150
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K020779
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/03/2019
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 Catalogue NumberTCT75
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/03/2019
Initial Report FDA Received Date09/25/2019
Patient Sequence Number1
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