MAUDE Adverse Event Report: MEDISAFE UK LTD. INNOWAVE PRO SONIC IRRIGATOR; WASHER/DISINFECTOR

Model Number PRO

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

The user facility reported via medwatch (b)(4) that preventive maintenance (pm) was unable to be completed on their ultrasonic cleaner due to back ordered pm parts.The user facility expressed safety and regulatory concern due to missed maintenance.No report of injury.

Manufacturer Narrative

The steris pcf pro sonic irrigator is a high-pressure, ultrasonic, flushing water disinfector for the healthcare market.It is intended to provide cleaning and intermediate-level thermal disinfection of surgical instruments, including lumened devices.The innowave pcf pro sonic irrigator subject of the reported event is not serviced or maintained by steris.The user facility is responsible for service, routine maintenance, and all preventive maintenance activities for the equipment.The user facility contacted steris via service request on (b)(6) 2022 to perform preventive maintenance activities for their innowave pcf pro sonic irrigator.Following the service contact on (b)(6) 2022, steris provided the user facility's biomedical technician with a purchase order.When the user facility approved the purchase order, the steris service technician proceeded to order all necessary components/parts for the billable preventive maintenance activity.Once all parts were received, the steris service technician completed the billable preventive maintenance on (b)(6) 2022.The steris service technician tested the innowave pcf pro sonic irrigator and returned the unit to service.In-between the service request activity on (b)(6) 2022 and the preventive maintenance activity on (b)(6) 2022 (10 days), user facility personnel continued to use the innowave pcf pro sonic irrigator as no issues were noted with the function or operation of the device.To ensure that the innowave pcf pro 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.These checks are not a substitute for regular servicing and maintenance by a suitably qualified technician.Should the device require service or repair the user facility should contact steris service.The user manual states (pp.111), "daily cleaning and inspection: the equipment owner should review and set a cleaning and inspection procedure that is appropriate for their frequency and manner of use." 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.

Manufacturer Narrative

This follow-up report is being submitted as there was a typo in the previous mdr (9617134-2022-00006) and all references to innowave pcf pro sonic irrigator should be innowave pro sonic irrigator.

• Brand Name: INNOWAVE PRO SONIC IRRIGATOR
• Type of Device: WASHER/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, OH 44060 ; 4403927453
• MDR Report Key: 15446925
• MDR Text Key: 306285698
• Report Number: 9617134-2022-00006
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 00724995152741
• UDI-Public: 00724995152741
• 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,Followup
• Report Date: 09/19/2022

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
• Device Operator: Health Professional
• Device Model Number: PRO
• Device Catalogue Number: IWPRO60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• 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