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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE Back to Search Results
Model Number TX30B
Medical Device Problem Code Failure to Form Staple (2579)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/25/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that during a thoracotomy, the staples did not form.The procedure was completed with a alternate device with no patient consequence.No additional information is available at this time.
 
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Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
*  00969
MDR Report Key10560495
Report Number3005075853-2020-04771
Device Sequence Number1218761
Product Code GDW
UDI-Device Identifier10705036003311
UDI-Public10705036003311
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
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/25/2020
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 Date10/31/2024
Device Model NumberTX30B
Device Catalogue NumberTX30B
Device Lot NumberT4116W
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/25/2020
Initial Report FDA Received Date09/21/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
(B)(4)
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