MAUDE Adverse Event Report: ARTHROCARE CORP. CAPSURE 30 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC1830-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Foreign zip code (b)(6).
Event or Problem Description
It was reported that during a wrist arthroscopy, the tip of the wand 'capsure 30' was detached from the shaft upon pulling it out of the patient's hand.The case was completed with a delay of 5min using the angle probe 'vulcan micro tac-s' as backup device.There was no harm and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Foreign zip code (b)(6).
Event or Problem Description
It was reported that during a wrist arthroscopy, the tip of the wand 'capsure 30' was detached from the shaft upon pulling it out of the patient's hand.The case was completed with a delay of 5min using the angle probe 'vulcan micro tac-s' as backup device.There was no harm and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a wrist arthroscopy, the tip of the wand 'capsure 30' was detached from the shaft upon pulling it out of the patient's hand.Tip got loosened and dangled out of the shaft but still connected.The detachment happened just when the tip is about to exit the skin and not inside the patient.The case was completed with a delay of 5 minutes using the angle probe 'vulcan micro tac-s' as backup device.There was no harm and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned instrument shows no manufacturing abnormalities.The tip where the electrode sits has been detached from the wand.Product was out of the original packaging.No packaging returned.A functional evaluation could not be conducted due to the wands detached tip with the electrode.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 found no similar reported events.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.A clinical review states no relevant clinical information was provided; therefore, a thorough medical investigation could not be rendered nor could the clinical root cause of the reported failure be determined.Based on the information provided, the detachment happened just when the tip is about to exit the skin and not inside the patient.A single undated photo was provided, that supports the compliant.According to the report, the case was completed with a delay of 5min using the angle probe 'vulcan micro tac-s' as backup device.Since there was no alleged harm to this patient, no further clinical/medical assessment is warranted at this time.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: 1) hitting the device tip against a hard surface.2) excessive force.3) mechanical displacement of tissue through applied force.No containment or corrective actions are recommended at this time.

• Brand Name: CAPSURE 30 ICW
• Common Device Name: 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: 13509985
• Report Number: 3006524618-2022-00054
• Device Sequence Number: 20145644
• Product Code: GEI
• UDI-Device Identifier: 00817470001907
• UDI-Public: 00817470001907
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033584
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2024
• Device Model Number: AC1830-01
• Device Catalogue Number: AC1830-01
• Device Lot Number: 2071954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 06/30/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 02/22/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown