MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number UM-S20-17S

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) informed the customer that the probe was being reprocessed and stored incorrectly.The probe should be hung.Tac also, recommended that the customer contact the aer manufacturer to ensure it is validated to clean the probe.The device will not be returned for evaluation.The instruction manual provides statements and warnings to maintain the probe.Warnings and cautions after using this instrument, reprocess and store it according to the instructions given in chapters 5 through 7.Using improperly or incompletely reprocessed or stored instruments may cause patient cross-contamination and/or infection.Do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe.Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts.7.6 cleaning, disinfection, and sterilization procedures for accessories and reprocessing equipment this section includes the cleaning and sterilization procedures for the accessories.For all other parts, refer to their respective instruction manuals.This section describes the reprocessing procedures of the accessories listed below.For the reprocessing procedures applicable to each reusable part, see table 6.1 in section 6.1, ¿compatibility summary¿ on page 30.The water-resistant cap (mh-244) is designed to be reprocessed attached to the ultrasonic probe as described in section 7.2, ¿cleaning process¿ on page 37 and sections 7.3, ¿high-level disinfection process¿ on page 40 and 7.4, ¿glutaraldehyde sterilization process¿ on page 42.If it is required to reprocess the water-resistant cap alone, follow the procedure given in this section.Warnings the storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Storing the ultrasonic probe in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays may damage the components or present an infection-control risk.

Event Description

The service center was informed that the probe was incorrectly reprocessed.The customer reported that the probe is placed in the medivator automatic endoscope reprocessor (aer) and leaving the end with the waterproof cap outside with a glove on it.The customer also stated the facility¿s probes were stored coiled up in sterile bags and placed on a shelf.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer final investigation.The following sections were updated, d4, d10, g4, g7, h2, h4, h6 and h10.As stated previously the reported event was not confirmed.In addition, an investigation was performed by the legal manufacturer based off of the information provided.1.A review of similar complaints both at the specific facility and in general was performed with no similar complaints identified.This will be trended.2.A review of the ifu was performed and it was confirmed the ifu gives instruction on proper cleaning and sanitization.3.A review of the dhr was performed and there were no issues found within the record associated to the reported event.4.A review of service records and repair records was performed.No repair information for the past year for the product was observed.Conclusion: a root cause could not be definitively identified.The most probable cause from the investigation results was determined to be human error in which the facility may have implemented an incorrect reprocess procedure.· it is stated in the instruction manual that cleaning and sanitization (or sterilization) should be performed after each case.· it is somewhat likely that the reprocess methods in accordance with the instruction manual were not implemented.

• Brand Name: ULTRASONIC PROBE
• Type of Device: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10501525
• MDR Text Key: 224635742
• Report Number: 8010047-2020-06281
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UM-S20-17S
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 12/24/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1