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

Model Number	TX30B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Batch # unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.  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 and could not be fired at all? or was the trigger advanced with no staples deployed? were there any patient consequences?.
Event or Problem Description
(b)(6) 2020.The stapler miss fired, no staples came out when fired.Caused quite a bit of hassle during the case, adding an extra 2+ hours on table.
Additional Manufacturer Narrative
(b)(4).Date sent: 03/10/2020.Additional information was requested, and the following was obtained: did the device lock out and could not be fired at all? or was the trigger advanced with no staples deployed? were there any patient consequences? response: the reporter have advised the rep at the time of reporting, no further information available for this case.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9707641
• Report Number: 3005075853-2020-00997
• Device Sequence Number: 1367361
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 09/30/2024
• Device Model Number: TX30B
• Device Catalogue Number: TX30B
• Device Lot Number: T40Y6C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/16/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/10/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown