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

Catalog Number	SW112
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p92e6p.Device analysis: the analysis results found that the sw112 cartridge was received with the cartridge plate dislodged.In addition, the tyvek was returned along with the instrument.Scratches were found in different areas of the cartridge body indicating that excessive force was used to introduced the asd instrument.The potential reason of the loading or unloading failure can be caused due to incorrect instrument usage.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
Surgeon could not arm this particular reload from cassette into the suture assistant device.No patient consequences.No delay in surgery.

• Brand Name: ENDOSUTURE RELOAD SUTURE ASST
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7328415
• Report Number: 3005075853-2018-08465
• Device Sequence Number: 10793064
• Product Code: GCJ
• UDI-Device Identifier: 20705036002908
• UDI-Public: 20705036002908
• Combination Product (Y/N): N
• PMA/510(K) Number: K972679
• 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
• Report Date (Section B): 01/24/2018

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: 04/30/2022
• Device Catalogue Number: SW112
• Device Lot Number: P4RJ7W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1