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

Catalog Number	601-00100
Health Effect - Clinical Code	Swelling (2091)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented abnormal swelling after procedure.Despite several attempts to get more information regarding patient condition, no response has been received from reporter.
Additional Manufacturer Narrative
The reported device, used for treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.There are several factors that could contribute to the reported event and are outlined in the ifu such as: do not use in patients in whom prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired.As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure.Placement of supporting sutures or other closure augmentation may be required to ensure closure integrity when excessive tension on the wound edge is or may be present, e.G.High-tension areas, excisions, or wounds that may experience significant swelling.Preoperative and operative procedures, including proper patient selection, knowledge of techniques, and proper device selection are important considerations when using the device.

• 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: 8015153
• Report Number: 3006524618-2018-00569
• Device Sequence Number: 16509896
• Product Code: OLL
• UDI-Device Identifier: 00817470006452
• UDI-Public: 00817470006452
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 601-00100
• Device Lot Number: VN12163
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other