MAUDE Adverse Event Report: ARTHROCARE CORP. STARVAC 90 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number ASC4251-01

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the packing seal of the starvac 90 icw packaged was broken.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

The reported device was received for evaluation.A visual inspection found the orange tamper seal is intact.The label that seals the opposite end of the package was torn.The sterile package was not damaged.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the packaging process found that tamper seal and label are applied to the packaging.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was no way to determine if the device contributed to the reported event.The complaint was confirmed, but the root cause could not be determined.Factors that could have contributed to the reported event include damage caused by shipping or handling.No containment or corrective actions are recommended at this time.

• Brand Name: STARVAC 90 ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12594325
• MDR Text Key: 275426529
• Report Number: 3006524618-2021-00959
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001716
• UDI-Public: 00817470001716
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: ASC4251-01
• Device Catalogue Number: ASC4251-01
• Device Lot Number: 2071159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female