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

Catalog Number	ASH4830-01
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4) h3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that the super multivac 50 ifs wand sterile packaging was not sealed completely.It is unknown whether the event occurred during surgery, and there was no confirmation of patient involvement or a surgical delay.The procedure was completed using a smith and nephew back-up device, and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found two partially in-frame photos.In image 1, the back of the device is visible along with its label, confirming the device identifiers.In image 2, the front of the device is shown and the package is slightly open.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 identified no similar reported events, classifying this as an isolated occurrence.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 packaging procedure found after packaging of the device the tyvek lids are inspected to ensure that is not damaged by cuts, holes, tears, embedded particles, stains, among others.If any damage is found, the damage must be notified to the supervisor.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include improper handling.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: h3, h6: the reported device was received for evaluation.A visual inspection revealed it was returned with its outer packaging opened and the inner packaging fully sealed.The cover of the inner packaging is shifted slightly but it is still fully sealed.The device is not going to be removed from the packaging.An image evaluation was performed and found two partially in-frame photos.In image 1, the back of the device is visible along with its label, confirming the device identifiers.In image 2, the front of the device is shown and the package is slightly open.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 identified no similar reported events, classifying this as an isolated occurrence.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 packaging procedure found after packaging of the device the tyvek lids are inspected to ensure that is not damaged by cuts, holes, tears, embedded particles, stains, among others.If any damage is found, the damage must be notified to the supervisor.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include improper handling.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SUPER MULTIVAC 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 21984742
• Report Number: 3006524618-2025-00211
• Device Sequence Number: 12840417
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 817470004908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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 Catalogue Number: ASH4830-01
• Device Lot Number: 2149994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 09/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/16/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• 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