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

Catalog Number	AC4050-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during wrist joint debridement, the microblator tip fell off while in use.Suction was used to remove the device from the patient however, not all pieces were able to be retrieved.The procedure was completed with delay of under 30 min and using a s+n backup device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.The device is non-implantable, with limited contact of less than 24 hours with tissue and bones.Therefore, we cannot rule out the possibility of mri restrictions, pain, and micro-motion/migration of the retained microblator tip.Since no further harm has been alleged to this patient, no further clinical/medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.A review of manufacturing records for the reported lot number found no non-conformance's or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Risk management documents review found no additional risks that require to be added to the reference document.Visual inspection under magnification of the wand shows a detached tip with discoloration on the return electrode.The insulation at the tip is compromised.There are no manufacturing abnormalities visually observed with the returned wand.For a functional evaluation in the device was plugged in to a controller and just after activating the controller system reports an error e-4 ¿wand short¿.The functional test was repeated with the same result.The device could not be activated.The wand was dissected and continuity tested.There was no direct short measurable with the multimeter.The complaint was verified as the device's tip was detached, the root cause was determined to be due to component failure.Factors, which may have contributed to the reported complaint include: (1) mechanical displacement of tissue through applied force (2) enlarge a surgical site (3) gain access to tissue as this may result in a damage to the device, and/or leading to patient injury.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: MICROBLATOR 30 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10139017
• Report Number: 3006524618-2020-00359
• Device Sequence Number: 11203064
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

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: 07/01/2022
• Device Catalogue Number: AC4050-01
• Device Lot Number: 2037547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention