MAUDE Adverse Event Report: ARTHROCARE CORPORATION AMBIENT HIPVAC 50 IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	72290004
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up of an arthroscopy procedure, when the blister of the ambient hipvac device was taken out of the box, the packaging had a hole.However, there was no sign of tampering on the cardboard package containing it.The procedure was delayed for 5 minutes.Back-up device was available.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned instrument shows no manufacturing abnormalities.The device was returned in its original packaging.There is a marked hole in the tear-able packaging.The package is otherwise not opened.The hole has indentions of a puncture impact event.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the heat seals visual integrity, found that the assembler must inspect that the tyvek lids / pouches are not damaged by (cuts, holes, tears, embedded particles, stains, among others), if any damage is found must be separated and the leader or supervisor notified.The complaint was verified and the root cause is not established.Factors that could have contributed to the reported event include dropping the device, hitting the device with another object, or stacking other devices on top causing pressure which could puncture the package.No containment or corrective actions are recommended at this time.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16665727
• Report Number: 3006524618-2023-00114
• Device Sequence Number: 5933862
• Product Code: GEI
• UDI-Device Identifier: 00885556614686
• UDI-Public: 00885556614686
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 10/27/2025
• Device Model Number: 72290004
• Device Catalogue Number: 72290004
• Device Lot Number: 2105336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown