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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE Back to Search Results
Catalog Number PLE60A
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is 2019.Event day and event month were not provided.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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 an unknown procedure, the doctor was performing surgery and after two reloads, gun was not opened.It is unknown how procedure was completed.There was no patient consequence.
 
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Brand Name
PWRD ECH FLEX 60MM 44CM SHAFT
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key9079790
Report Number3005075853-2019-22146
Device Sequence Number2244315
Product Code GDW
UDI-Device Identifier10705036014300
UDI-Public10705036014300
Combination Product (Y/N)N
PMA/510(K) Number
K110385
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/26/2019
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 Expiration Date03/31/2021
Device Catalogue NumberPLE60A
Device Lot NumberR9307K
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/26/2019
Initial Report FDA Received Date09/17/2019
Patient Sequence Number1
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