MAUDE Adverse Event Report: GYRUS ACMI, INC FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number NT4F19115

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

The medical device was forward to the manufacturer for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.Once the investigation is available, this report will be updated.

Event Description

The service center was informed that during stone removal procedure, the user was unable to close or retract the basket after retrieving the stone.The basket was cut and then removed from the patient.The procedure was completed with a similar device.There was no longer stay or additional procedures required for the patient.There was no patient injury reported.

Manufacturer Narrative

The supplemental report is to provide the oem's (ep flex) investigation summary.The oem conducted a review of the device history records (dhr) and indicated the production of the concerned lot has been manufactured according to the valid specifications.There were no deviations noted as all process steps and all inspections have been done as prescribed.The oem stated that the investigation carried out by olympus clearly shows that the basket wires were cut by a laser and that the cause is therefore due to user error.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the physical evaluation.The device arrived in its original packaging.A visual inspection was performed on the received condition.The handle appeared to be intact and the slider was working properly.The wire was cut off 2cm from the end of the heat shrink on the proximal end.There was a 4 inch stretch of the sheath that was discolored/missing towards the distal end.The cause of the reported event could not be determined as the investigation is ongoing.If additional information becomes available, this report will be updated accordingly.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Type of Device: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8638979
• MDR Text Key: 146076862
• Report Number: 2951238-2019-00871
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4F19115
• Device Lot Number: 91804370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1