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

Catalog Number SW112

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

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 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
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7328415
• MDR Text Key: 102195019
• Report Number: 3005075853-2018-08465
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036002908
• UDI-Public: 20705036002908
• Combination Product (y/n): N
• PMA/PMN Number: K972679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1