MAUDE Adverse Event Report: ARTHREX, INC. SYNERGY INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number	SYNERGY INSUFFLATOR
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2022
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
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-3290-0004 was not holding pressure, and was making continuous clicking noises.The case was delayed an hour.The patient was not effected.Additional information 02/08/2022: on (b)(6) 2022, it was reported by a sales representative via email that an ar-3290-0004 insufflator does hold pressure and continues to make clicking noises.When hooked to the operative cannulas the pressure would drop to zero and fluid would backfill.The case was delayed an hour, extra anesthesia was needed.This was discovered during use in a lap chole procedure on (b)(6) 2022.
Additional Manufacturer Narrative
The device was received for evaluation.Device was shipped with the correct packaging; packaging had some damage.Device is in poor condition, both the lower and upper casing are bent, and the bottle gas connector is damaged (thread).Initial self-test passed; no errors occurred.Functional testing was performed, and the unit was found to be functioning per specifications.Complaint was not confirmed.Unit was found to be functioning per specifications.Pressure testing was performed, and the unit was found to be stable at all times.Un-related to the complaint, the damages sustained to the upper and lower casing most likely occurred, due to either transport damaged or the unit being dropped.No further action is indicated at this time.

• Brand Name: SYNERGY INSUFFLATOR
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• 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: 13529189
• Report Number: 1220246-2022-04475
• Device Sequence Number: 12040917
• Product Code: HIF
• UDI-Device Identifier: 04056702002824
• UDI-Public: 04056702002824
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K030837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: SYNERGY INSUFFLATOR
• Device Catalogue Number: AR-3290-0004
• Device Lot Number: 10674702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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