MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY ID; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CCU, ARTHREX SYNERGY ID
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the device has no signal.No additional information regarding a specific failure mode was provided.The problem was noticed before the surgery.There was no harm for the patient, operator or third party reported.No further information received.Update above 08-nov-2021: it was reported that during a laparoscopy surgery the monitor 32hl710s-w (sn (b)(4)) went black for 10 minutes during the surgery and it did not find any signal, neither dp nor sdi.It was confirmed that after replacing the monitor afterwards the error persisted with the new monitor.After the console ar-3200-0025 (sn (b)(4)) was replaced the error did not occur again.According to this test the console was causing the error.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully, but the surgical technique had to be switched to an open surgery.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
(misuse by user, moisture intrusion) it was confirmed that after replacing the monitor afterwards the error persisted with the new monitor" was confirmed.This evaluation determined that the reported event occurred due to moisture intrusion resulting from misuse.

• Brand Name: CCU, ARTHREX SYNERGY ID
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12895158
• Report Number: 1220246-2021-04002
• Device Sequence Number: 11634268
• Product Code: GCJ
• UDI-Device Identifier: 00888867351189
• UDI-Public: 00888867351189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: CCU, ARTHREX SYNERGY ID
• Device Catalogue Number: AR-3200-0025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown