MAUDE Adverse Event Report: SYMMETRY SURGICAL LGE STERILIZATION CONTAINER W/O LID.; TRAY, SURGICAL, INSTRUMENT

Model Number	131414
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The customer reported to an olympus representative, the large sterilization container without lid is not dry when it comes out of the sterilizers.However, the metal trays are dry when they come out of the sterilizers.No patient involvement.Attempts to retrieve additional information from the customer are in progress.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the customer.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
Additional information from the customer: it is reported the facility uses a twenty (20) minute dry time cycle.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, and the unknown information (device serial number, images, autoclave settings), the cause is unknown at this time.If additional information is obtained at a later date, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.

• Brand Name: LGE STERILIZATION CONTAINER W/O LID.
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYMMETRY SURGICAL; 253 abby road; manchester NH 03103
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12638507
• Report Number: 3003790304-2021-00154
• Device Sequence Number: 1443052
• Product Code: FSM
• UDI-Device Identifier: 00821925018358
• UDI-Public: 00821925018358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2021

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
• Operator of Device: Other
• Device Model Number: 131414
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 12/07/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/25/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 131416 LID FOR CONTAINER, UNKNOWN LOT/SERIAL; 131416 LID FOR CONTAINER, UNKNOWN LOT/SERIAL
• Patient Sex: Unknown