MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE

Model Number	XR60B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2020.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 an unknown procedure, when firing the tx60b, there was no staples in the reload.There were no patient consequences.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 08/21/2020.D4: batch # r5ad17.Device analysis: the analysis results showed that the xr60b reload arrived with no apparent damage and fully loaded with staples.In addition, the retainer staple was not received.The reload was tested for functionality with a test device.The device fired and formed all the staples as intended.The device fired without any difficulties.However, 2 staples were noted to be missing along the staple line, these staples do not create a fluid path.Although there is no direct evidence of use error, the instructions for use do contain the following caution: do not grasp the firing trigger before the instrument is to be fired, an inadvertent activation of the firing trigger, which could prematurely staple deployment.The event described could not be confirmed as the staples were present in the reload and it performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10323288
• Report Number: 3005075853-2020-03792
• Device Sequence Number: 19796861
• Product Code: GDW
• UDI-Device Identifier: 10705036013464
• UDI-Public: 10705036013464
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• 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): 07/01/2020

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 Expiration Date: 09/11/2023
• Device Model Number: XR60B
• Device Catalogue Number: XR60B
• Device Lot Number: R4126J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1