MAUDE Adverse Event Report: ARTHROCARE CORPORATION ENTACT SEPTAL STAPLER, 1-PACK; SEPTAL STAPLER/ABSORBABLE STAPLES

Model Number	601-00100S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the first stapler failed to dispense any sutures, back up device was used and sutures did not stay in the septum.A delay greater than 30 minutes was reported.No patient injuries were reported.Local anesthesia was used.A backup was used.
Additional Manufacturer Narrative
Please note that this complaint was already reported under manufacturers report number 3006524618-2018-00334.Please disregard current report.

• Brand Name: ENTACT SEPTAL STAPLER, 1-PACK
• Common Device Name: SEPTAL STAPLER/ABSORBABLE STAPLES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7736259
• Report Number: 3006524618-2018-00395
• Device Sequence Number: 1040339
• Product Code: OLL
• UDI-Device Identifier: 00817470006469
• UDI-Public: (01)00817470006469(17)201023(10)VN11446
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: 10/23/2020
• Device Model Number: 601-00100S
• Device Catalogue Number: 601-00100S
• Device Lot Number: VN11446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1