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

Model Number	TX60G
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).Date of event: 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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that partial firing of staples.Information provided is that resident fired device and may be user error not going plastic to plastic.Oversew of staple like required.The procedure was completed successfully with no patient consequences or change of post-operative care.Procedure: unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/15/2020.D4: batch # u5ar7e.Device analysis: the analysis results showed that the tx60g device arrived with no apparent damaged and with a reload loaded on the device.The reload was received fully fired.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria.Although there is no direct evidence of use error, the instructions for use do contain the following caution: the firing stroke must be completed.Do not partially fire the instrument.Incomplete firing can result in malformed staples, incomplete cut line, bleeding, and leakage from the staple line and/or difficulty removing the device.The event described could not be confirmed as the device 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: 10574792
• Report Number: 3005075853-2020-04855
• Device Sequence Number: 19601533
• Product Code: GDW
• UDI-Device Identifier: 10705036003359
• UDI-Public: 10705036003359
• 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): 09/01/2020

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: 01/29/2025
• Device Model Number: TX60G
• Device Catalogue Number: TX60G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1