MAUDE Adverse Event Report: SYMMETRY SURGICAL CYSTOSCOPY RESECTION TRAY - DOUBLE LAYER

Model Number	ST-CR2
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated at olympus san jose service repair center.A visual inspection on the as is received condition of the device was performed.The device was returned in a white rectangular box.The condition of the white box has several deep horizontal creases as well as a portion that appears punctured.The corner edges of the white box are also severely worn which could have been caused by heavy impact.Inside the white box contained the tray which was accompanied by some bubble wrap at the bottom of the tray and a manual which was taped to the lid of the tray.Multiple cracks on one of the corners of the lid were determined.It appears there are no missing parts of the lid of the tray where the cracks are located.The tray inside was inspected and the tray appears brand new as it is still covered in plastic wrap.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported , during device receipt inspection, the lid to the tray was observed to be damaged.There was no patient involvement on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Oem (original equipment manufacturer) review of the device history record showed all records the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor the field performance of this device.

• Brand Name: CYSTOSCOPY RESECTION TRAY - DOUBLE LAYER
• Common Device Name: CYSTOSCOPY RESECTION TRAY
• 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: 12735338
• Report Number: 3003790304-2021-00160
• Device Sequence Number: 14592075
• Product Code: FSM
• UDI-Device Identifier: 00821925007864
• UDI-Public: 00821925007864
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K944025
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: Health Professional
• Device Model Number: ST-CR2
• Device Lot Number: 000237517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• 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: 10/12/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown