MAUDE Adverse Event Report: GETINGE DISINFECTION AB WD15 CLARO; DISINFECTOR, MEDICAL DEVICES

Model Number	WD15 CLARO
Medical Device Problem Codes	No Apparent Adverse Event (3189); Device Handling Problem (3265); Sharp Edges (4013)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2021, getinge became aware of an issue with wd15 claro washer disinfector.As it was stated, the list in the door has been bended and one of the users cut himself on the edge of the groove for the hatch gasket.As it was provided, operator did not need a medical intervention, however taking under consideration the worse case scenario which could lead to the serious injury we decided to report this case to competent authorities.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 15th february 2021 getinge received a customer product complaint concerning sharp edge on the exposed groove for the gasket¿s hatch.The involved device is a wd15 claro (ge15) with the serial number: (b)(6) and udi number (b)(4) manufactured on 2019-12-02 and installed in the facility on 2020-03-31.Performed trend review shows that there is no trend observed with this specific complaint type.When considering the device part, the situation is rather isolated to this particular customer.The complaint at hand included allegation of an adverse situation related to a cut sustained as an effect of operator¿s contact with the exposed edge.No documented proof of the cut was received.The contact was considered to be made in error, namely not in line with usual working practice.Review of the device¿s user manual `getinge wd15 claro ge15 user manual 6001396602` rev.H showed however no specific point in the document that would warn the user and prevent reaching inside the chamber without pulling out the top tray from the machine first.At that time and with the information gathered we decided to report the incident to the competent authorities in abundance of caution.Conducted investigation consist the test performed in accordance to ul 1439 - standard for safety tests for sharpness of edges on equipment with the sharpness tester identified by number #7426.During the test five different devices were evaluated.As a result none of the tested devices had confirmed sharp edges in the alleged place that could led to cut-type injury when contacted during normal use or user maintenance.To sum up, the most probable root cause which contributed to the situation described was connected with the insufficient instructions available for the user in regards to the loading/ unloading procedure.This directly led to the situation when the operator touched the edge and alleged to cut the skin.However, performed evaluation proofed that the edges are not sharp, thus the product malfunction was not confirmed.When the event occurred, the washer disinfector was directly involved in the reported incident however it is concluded to have met its specification as there was no product deficiency conform.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature.We confirmed that even if the edge of the gasket groove is exposed it does not have a sharp edge and is not likely to bring on any hazardous situation for the operator.Should we receive any further customer product complaints of this kind, we will not see them as reportable under vigilance reporting requirements as long as there would be no further situation associated with the product issue.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.

• Brand Name: WD15 CLARO
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 11378826
• Report Number: 9616031-2021-00006
• Device Sequence Number: 17108518
• Product Code: MEC
• UDI-Device Identifier: 07340153700239
• UDI-Public: (01)07340153700239
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: No Information
• Device Model Number: WD15 CLARO
• Device Catalogue Number: GE15-003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 06/11/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 04/02/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other