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

Catalog Number	TCT10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event month and day unknown.Only year (2018) is known.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.
Event or Problem Description
It was reported that during an unknown procedure, some staples did not form perfect b shape so the surgeon had to do reinforce suture.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # k5e723.The analysis results found that the tct10 device was received with no apparent damage and with a cartridge reload loaded in the device.The reload was received fully loaded with staples and with the swing tab in the unlocked position and the left gripping surface was broken off.The instrument was tested for functionality with a test cartridge reload and it performed as intended.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper shape.While no conclusion could be reached as to how the gripping surface became damaged, it should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.In addition, the analysis results found that one trt10 reload was received with no apparent damage and fully loaded with staples.The reload was tested for functionality with a test device and it fired, cut, and formed all the staples as intended.The device fired with no difficulties and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.
Additional Manufacturer Narrative
(b)(4).Batch # k5e723.Additional manufacturer narrative/corrective data - device evaluation summary.Updated device evaluation summary: the analysis results found that the tct10 device was received with no apparent damage and with a cartridge reload loaded in the device.The reload was received fully loaded with staples and with the swing tab in the unlocked position and the left gripping surface was broken off.The instrument was tested for functionality with a test cartridge reload and it performed as intended.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper shape.The condition on the returned reload is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and proper loading.Please refer instructions for use.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Performed by e.Navarro.,the batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.In addition, the analysis results found that one trt10 reload was received with no apparent damage and fully loaded with staples.The reload was tested for functionality with a test device and it fired, cut, and formed all the staples as intended.The device fired with no difficulties and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7939187
• Report Number: 3005075853-2018-13307
• Device Sequence Number: 14037992
• Product Code: GDW
• UDI-Device Identifier: 10705036003052
• UDI-Public: 10705036003052
• 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,Followup
• Report Date (Section B): 09/11/2018

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: 10/09/2018
• Device Catalogue Number: TCT10
• Device Lot Number: K4DN55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/07/2018; 01/28/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/30/2018; 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RELOAD - TRT10