MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REL UNIT ETHIBOND CANOE NEEDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	SW110
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that the outer packaging says the suture cartridge is a 0-suture cartridge, but the cartridge housing says the product is a 2-0 suture cartridge.No patient involvement occurred.
Additional Manufacturer Narrative
(b)(4).Batch # p93h2l.The analysis results found that three sw110 devices were returned inside its package unopened.Upon visual inspection, it was confirmed that the reload cover did not match with the product labeling.This condition is most likely related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: REL UNIT ETHIBOND CANOE NEEDLE
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7731634
• Report Number: 3005075853-2018-11680
• Device Sequence Number: 2770649
• Product Code: GCJ
• UDI-Device Identifier: 20705036002892
• UDI-Public: 20705036002892
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K972679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: 08/31/2022
• Device Catalogue Number: SW110
• Device Lot Number: P4T267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/04/2018
• Patient Sequence Number: 1