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

Model Number 131414

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

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 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.

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 Description

Additional information from the customer: it is reported the facility uses a twenty (20) minute dry time cycle.

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.
• Type of Device: 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
• MDR Text Key: 276588821
• Report Number: 3003790304-2021-00154
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 00821925018358
• UDI-Public: 00821925018358
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 131416 LID FOR CONTAINER, UNKNOWN LOT/SERIAL; 131416 LID FOR CONTAINER, UNKNOWN LOT/SERIAL