MAUDE Adverse Event Report: ARTHREX, INC. SALES LEVEL,CCU,SYNERGY HD3,TURRET; LAPAROSCOPE

Model Number	SALES LEVEL,CCU,SYNERGY HD3,TURRET
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
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
On 27th dec 2023, one ar-3200-0001t device was used during a trauma surgery, but the screen displayed intermittently, which caused a 30-minute delay of the procedure and resulted in increased blood loss from the patient.No additional anesthesia was used due to the delay and blood loss was treated by the surgeon.The instrument was repaired by the hospital during the surgery and cannot be returned right now.The patient is well now.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is not confirmed.The device was not received for evaluation, and no photo was provided for investigation.The most likely cause for the reported failure can be attributed to wear and tear of the device by extended usage in the field¿device manufacture date 2015.However, the complaint cannot be confirmed without the return of the device for evaluation.Refer to the system item details pictures.

• Brand Name: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Common Device Name: LAPAROSCOPE
• 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: jared engle ; 8009337001
• MDR Report Key: 18678066
• Report Number: 1220246-2024-00886
• Device Sequence Number: 20637207
• Product Code: GCJ
• UDI-Device Identifier: 00888867029163
• UDI-Public: 00888867029163
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071756
• 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): 11/26/2024

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 Model Number: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Device Catalogue Number: AR-3200-0001T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown