MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PCF SONIC IRRIGATOR; DISINFECTOR

Model Number PCF

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Steris innowave sonic irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments.The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.The user facility's biomed was made aware of the backordered parts and that the preventive maintenance (pm) activity was unable to be completed until all components were available.User facility personnel continued use of the innowave pcf sonic irrigator as no issues were noted with the function or operation of the device.Pm is scheduled every 6 months for the innowave pcf sonic irrigator.All components contained in the pm pack were last replaced on (b)(6) 2022 prior to the event during preventive maintenance that was timely completed within the 6-month period.Once all pm parts were available, steris completed the pm activity on (b)(6) 2023.To ensure that the innowave pcf sonic irrigator operates within its design parameters, it is important that daily and weekly checks are performed on a regular basis by the user of the device.Should the device require service or repairs, the user facility should contact steris service.The innowave pcf sonic irrigator user manual states (36), "checks before every cycle: 1.Clean recirculation filters in wash tank 2.Dry the water level sensors 3.Check o-ring attached to all tank docking ports 4.Check condition of hoses connecting basket to ports in wash tank 5.Check that wash chamber is free from any debris or deposits 6.Check the spray nozzles for blockage." the user manual further states (36), "daily checks: 1.Automatic control test by selecting a recent printout and compare parameters with the first printout generated after installation 2.Check that there is sufficient chemical for the days planned use 3.Check and clean all internal surfaces above the water line 4.Check and clean all external surfaces including lid seal 5.Check lid and lid seal for any damage." the pm pack subject of the reported event consists of three different components: 4 tank basket docking seals, 1 silicone tank filter o-ring, and 2 gas struts.The tank basket docking seal is used to seal the pressurized water connection into the wash basket.Should this component malfunction or require replacement the sonic irrigator will signal an alarm (error 56).The silicone tank filter o-ring is used to seal the tank drain filter.The tank drain filter prevents any foreign matter from entering the cleaning circuit.Should the o-ring component malfunction or require replacement the back pressure and vibration of the device could subsequently cause the tank drain filter to move from its seated position.The function of the gas struts are used to keep the device's lid open during loading and unloading of the unit.Should a gas strut malfunction or require replacement the lid would not stay open.If the wash cycle fails to achieve anyone of its predefined parameters the system will report a cycle failure.An audible alarm will sound and the relevant error code will be shown in the display.The printer will output the error code with a brief description and the value of the parameter(s) causing the error with their thresholds/limits.There would be no risk to patients as a result of the device requiring service or repair should a predefined parameter not be met.The user manual states (14), "if a wash cycle fails to achieve any one of its predefined parameters the system will report a cycle failure.An audible alarm will sound and the relevant error code will be shown in the display.The printer will output the following information: the error code with a brief description.The value of the parameter(s) causing the error with their thresholds/limits.The si pcf has been designed to perform within strict and carefully controlled tolerances." steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.

Event Description

The user facility reported via medwatch report (mw5115425) that preventive maintenance (pm) on their innowave pcf sonic irrigator was unable to be completed due to pm parts being on backorder.The user facility expressed safety and regulatory concern due to missed maintenance.No report of injury.

• Brand Name: INNOWAVE PCF SONIC IRRIGATOR
• Type of Device: DISINFECTOR
• Manufacturer (Section D): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer (Section G): MEDISAFE UK LTD.; unit 7 & 8, dunmow road; bishops stortford; hertfordshire, CM23 5GZ; UK CM23 5GZ
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor; 4403927453
• MDR Report Key: 16725206
• MDR Text Key: 313650714
• Report Number: 9617134-2023-00002
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995152710
• UDI-Public: 00724995152710
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Model Number: PCF
• Device Catalogue Number: IWPCF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1