MAUDE Adverse Event Report: SYMMETRY SURGICAL STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY

Model Number ST-CR

Device Problems Break (1069); Component Missing (2306)

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

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device was received at olympus (b)(6) site for initial evaluation and investigation.A visual inspection on the as is received condition of the device was performed.The device was returned in a brown box which has several creases throughout the box.Inside the box contained some bubble wrap and thin padded sheets that covered the tray.The tray appears to have no scratches, dents or deformities however, it was observed that one side of the tray where the handles are located, the metal rod that holds the clip in place is out of place and not securely locked in.It was verified that the metal rod is missing a washer on each side to keep the metal rod securely in position.The missing washers were not returned for evaluation and was not found inside the brown box or tray which returned with the device.It was confirmed that the other handle on the other side of the tray has a washer on both ends of the metal rod and is securely locked in place.The subject device is being shipped to the oem (original equipment manufacturer) for investigation.This report will be supplemented accordingly following investigations.

Event Description

It was reported that during installation, the handle was broken on the lid.There was no patient involvement, no user injury reported due to the event.This report is being submitted for the handle was broken on the lid, metal rod is missing a washer on each side to keep the metal rod securely in position.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The subject device was returned to the oem (original equipment manufacturer) for evaluation.Investigation from oem below: the critical step was accomplished by an experienced operator and followed the approved work instruction.The lid was an injected molded part which requires less preparation for proper assembly and less applicable failure modes than if it were a thermoformed part.Reviewed returned components without no objective evidence of sterilization.Focused on the lid for any evidence of form fit or function and also the pin and assembly.The most likely assignable cause is that the retention washers were never assembled with this one injection molded lid.The dhr (device history record) reconciliation of components indicated that the washers were available for assembly and that no additional parts were left over.This product is sampled at final and the sample inspection did not discover the defect issue.The dhr was reviewed for the product and there was nothing on the dhr review that would lead to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY
• Type of Device: STERILIZATION TRAY, SINGLE LAYER CYSTOSCOPY
• Manufacturer (Section D): SYMMETRY SURGICAL; 253 abby road; manchester NH 03103
• MDR Report Key: 12254082
• MDR Text Key: 264784412
• Report Number: 3003790304-2021-00129
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 00821925007857
• UDI-Public: 00821925007857
• Combination Product (y/n): N
• PMA/PMN Number: K944025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST-CR
• Device Lot Number: 000216591
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1