MAUDE Adverse Event Report: GYRUS ACMI, INC- BARTLETT HIGH SPEED DRILL HAND PIECE AND ATTACHMENTS STERILIZATION TRAY; TRAY, SURGICAL, INSTRUMENT

Model Number	HSDHP200TRAY
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the residual water on the device tray cannot drain water properly after cleaning due to too much surface and few holes in the filter basket.It was noted , as a result, water can remain in the screens that can lead to contamination and potential hazards to patients.Therefore, user will use its own trays.It was noted that the subject tray was not even used.The issue found during receipt inspection.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
The subject device has not returned for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Due to the device not being returned, a physical inspection could not be conducted.Product quality assessment determined that water remaining in the tray after sterilization could potentially cause germination which could lead to risk of patient infection if device is exposed/contaminated.Because the reported complaint is a user preference/suggestion and not a true device failure, a root cause cannot be associated with the complaint.Olympus will continue to monitor the field performance of this device.

• Brand Name: HIGH SPEED DRILL HAND PIECE AND ATTACHMENTS STERILIZATION TRAY
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC- BARTLETT; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15161937
• Report Number: 1037007-2022-00015
• Device Sequence Number: 5463868
• Product Code: FSM
• UDI-Device Identifier: 00821925035669
• UDI-Public: 00821925035669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT-FSM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: HSDHP200TRAY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown