MAUDE Adverse Event Report: ARTHREX INC. OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AR-9705A-90
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.At this time, it cannot be determined how the device may have caused or contributed to the surgeon's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair procedure, the surgeon was attempting to use an opes 90° toothbrush aspirating ablator during use, the surgeon experienced an electrode shock in his hand through the coolcut hand piece.The case was completed using the same device with no further issues.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission to reflect device evaluation.Device history record review revealed nothing relevant to this event.Complaint not confirmed.The evaluation of the complaint device did not reveal anything relevant to the event.The cause of the event cannot be determined.This is the first complaint of this type for this part/ lot combination.The potential causes of this event are being communicated to the event reporter.
Event or Problem Description
It was reported that during a rotator cuff repair procedure, the surgeon was attempting to use an opes 90° toothbrush aspirating ablator during use, the surgeon experienced an electrode shock in his hand through the coolcut hand piece.The case was completed using the same device with no further issues.

• Brand Name: OPES 90, ASPIRATING ABLATOR, TOOTHBRUSH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6798113
• Report Number: 1220246-2017-00299
• Device Sequence Number: 772434
• Product Code: GEI
• UDI-Device Identifier: 00888867062627
• UDI-Public: 00888867062627
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K023986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: AR-9705A-90
• Device Lot Number: 1606010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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