MAUDE Adverse Event Report: ARTHROCARE CORPORATION SUPER MULTIVAC 50 ICW; ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R

Catalog Number ASC4830-01

Device Problem Break (1069)

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

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a left hip arthroscopy, the super multivac's metal tip was absent and later found inside the patient using x-rays.Performing additional dissection, the broken piece was successfully retrieved from the patient's body.The procedure was successfully completed with non-significant surgical delay using the same device.No further complications were reported.

Manufacturer Narrative

H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.An analysis of the customer provided image found the metal tip of the device inside a plastic jar.A clinical review states that no clinically supporting clinical documentation has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation cannot be rendered, and the definitive root cause of the reported adverse event could not be determined.The patient impact was the retained piece, the additional dissection, removal of the retained tip and the non-significant surgical delay.Further impact to the patient is not anticipated since no other complications were reported.Factors that could have contributed to the reported event include an impact inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: SUPER MULTIVAC 50 ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R
• 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: 17965394
• MDR Text Key: 326269640
• Report Number: 3006524618-2023-00398
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 00817470003550
• UDI-Public: 00817470003550
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 2122143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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