MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*45 ENDO LIN CUT RELOAD WH; STAPLE, IMPLANTABLE

Model Number	TR45W
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #t5ec9n.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 and the manufacturing criteria were met prior to the release of this lot/batch.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? or, did the device fully fire and stop during the automatic knife return? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? 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, the reload only fired halfway and the stapler didn't move.Scrub nurse replaced the reload and the case was closed without further problems.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/17/2020 investigation summary the analysis results found that one tr45w reload was received with no apparent damage and partially fired 1/10 and with the reload lock out spring normal.No functional test could be performed due to the condition of the reload.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device, make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lockout.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10291005
• Report Number: 3005075853-2020-03637
• Device Sequence Number: 859983
• Product Code: GDW
• UDI-Device Identifier: 10705036003182
• UDI-Public: 10705036003182
• 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): 06/21/2020

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: 10/11/2024
• Device Model Number: TR45W
• Device Catalogue Number: TR45W
• Device Lot Number: U4004X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1