MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE; DISLODGER, STONE, FLEXIBLE

Model Number NT4W18115

Device Problems Break (1069); Device Fell (4014)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available following the completion of the investigation, a supplemental report will be filed.

Event Description

Olympus received a report from a user facility stating that during the procedure, the basket/net was detached from the instrument.The detached piece could not be retrieved and will require additional intervention for removal.No additional information has been received at this time.

Manufacturer Narrative

The device history records for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of (b)(4) units were produced under this lot number with no associated noncomformances (ncrs), reported scrap or recorded process deviations relating to the reported failure.

Manufacturer Narrative

This report is being supplemented to provide additional information regarding the reported event.The device was returned to olympus for evaluation.The device was visually inspected and the complaint was confirmed as the basket was detached at the juncture between the core wire and the basket assembly.The basket along with the corresponding connector tube used to join the assemblies were not returned to olympus.Inspection of the core wire confirmed the presence of the specified welds, under magnification these welds appeared intact.Therefore it is believed that the welding process did not contribute to the failure.As the basket was not returned, a definitive root cause could not be determined.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Complaint history review did not identify any additional complaints attributed to this lot.Complaint trending revealed the current complaint rate falls within acceptable limits, no alerts or alarms have been triggered.Olympus will continue to monitor complaints for this device through regular trending activities as defined by olympus surgical technologies america quality management system procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information (h10) and corrected data (h10) regarding the reported event.Additional information received identified the patient underwent a second procedure and the device was successfully retrieved.Additionally, the procedure that was taking place when the reported event occurred was a ureter- ureterorenoscopy.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9937360
• MDR Text Key: 194359946
• Report Number: 2951238-2020-00411
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Lot Number: KR881024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention