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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE Back to Search Results
Model Number XR60B
Medical Device Problem Code Unsealed Device Packaging (1444)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/29/2019
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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.
 
Event or Problem Description
It was reported that during an unknown procedure, the packaging was imperfect, the package is opened, it is not under sterile status.The sterility was compromised.There were no patient consequences.
 
Additional Manufacturer Narrative
(b)(4).Date sent: 04/17/2020.Additional information received: the xr60b is not available to be returned for investigation.
 
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Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key9916810
Report Number3005075853-2020-01949
Device Sequence Number2718113
Product Code GDW
UDI-Device Identifier10705036013464
UDI-Public10705036013464
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,Followup
Report Date (Section B) 01/01/2020
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 Model NumberXR60B
Device Catalogue NumberXR60B
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/15/2020
Supplement Date Received by Manufacturer04/13/2020
Initial Report FDA Received Date04/02/2020
Supplement Report FDA Received Date04/17/2020
Patient Sequence Number1
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