MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOSUTURE SUTURE ASSISTANT; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	SW100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92162.Additional information: medwatch received.(b)(4).Investigation summary: the analysis results found that the sw100 device was received with no damage in the external components without a cartridge loaded.In an attempt to replicate the reported incident, the device was tested for functionality without a test cartridge.Upon functional testing, the instrument was examined and it was found to be functional.The device was then reloaded with a test cartridge and it was cycled, fired and it properly formed the knot.In addition, a sw110 cartridge (t92j5k) was received with the cartridge plate dislodged inside a plastic bag and the tyvek.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The potential reason of the loading or unloading failure can be caused due to incorrect instrument usage.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.- (b)(4).
Event or Problem Description
It was reported that during a hiatal hernia repair the device failed.They couldn't get it to work and the tip of the suture assist was detached.Doctor immediately saw and removed all the pieces from the surgical area and they checked for completeness of the instrument.It is unknown how the case was completed.No adverse patient consequences were reported.

• Brand Name: ENDOSUTURE SUTURE ASSISTANT
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9082993
• Report Number: 3005075853-2019-22176
• Device Sequence Number: 18860555
• Product Code: GCJ
• UDI-Device Identifier: 10705036002888
• UDI-Public: 10705036002888
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K972679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 12/31/2023
• Device Catalogue Number: SW100
• Device Lot Number: T9233T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Patient Age: 47 YR