MAUDE Adverse Event Report: ARTHROCARE CORP. ENTACT SEPTAL STAPLER, 3-PACK; SEPTAL STAPLER/ABSORBABLE STAPLES

Model Number	601-00100
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using an entact stapler (601-00100) on monday and the tip of the stapler broke.They said it was just a piece of plastic that broke off when they went to use.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.During the visual inspection, it was noted that there were implants still loaded in the unit.There is a significant amount of dried blood present on the tip of the stapler.The blue indicator is visible near the tip of the device.There are no signs of damage or detached components from the tip of the device.There are no manufacturing abnormalities visually observed with the returned device.Upon squeezing of the trigger using a test pad a staple was deployed as intended; therefore, the device performed as intended.The complaint could not be verified as visual evaluation did not show any detached components of the distal tip.A definite root cause could not be determined with confidence as it is possible that another device may be the culprit to the detached plastic or dried blood may have been interpreted as the detached component.A review of the manufacturing records for the device found no deficiencies associated with the alleged event.

• Brand Name: ENTACT SEPTAL STAPLER, 3-PACK
• Common Device Name: SEPTAL STAPLER/ABSORBABLE STAPLES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7142029
• Report Number: 3006524618-2017-00439
• Device Sequence Number: 13678322
• Product Code: OLL
• UDI-Device Identifier: 00817470006452
• UDI-Public: (01)00817470006452(17)200921(10)708018
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 09/21/2020
• Device Model Number: 601-00100
• Device Catalogue Number: 601-00100
• Device Lot Number: 708018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1