MAUDE Adverse Event Report: GYRUS ACMI, INC S-L,HLCL,3.0,4W,11,090,0T ,R; SURLOK HELICAL STONE BASKET

Model Number 5700006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus for evaluation.The exact cause of the reported event cannot be confirmed.If the device is returned at a later date, this report will be supplemented accordingly.A review of the dhr for this product has been conducted and all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

Event Description

Olympus was informed that during the middle to the end of a therapeutic cystoscopy with removal of a right ureteral stent, the patient had a large, hard stone that required fragmentation for removal.The basket broke when it was removed from the patient.There were no device fragments that broke off or fell into the patient.There was no bleeding reported.A second device from the same lot was used and also broke.The procedure was completed using a third device from a different lot.There was patient injury reported.1 of 2 devices.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.The referenced device was returned in the original packaging and the lot number was confirmed as mk715070.A visual inspection on the received condition found the basket was deployed and the distal end was detached from the handle.The two wires on the basked were broken in addition the core wire was detached approximately 2 inches from the blue rubber nosecone.Despite being detached from the distal end, the slider and lock functioned as intended.This damage is indicative of overloading.The basket may become snagged on a stent or on the scope itself, upon withdrawal external stress is placed on the core causing it to snap.During retraction the basket may become over tightened on the calculus/foreign body placing excessive stress on the individual wires leading to their fracture.The instruction manual for device provides cautions that states, "the surlok helical stone basket is a delicate precision instrument and must be handled with care".

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the aware date.

• Brand Name: S-L,HLCL,3.0,4W,11,090,0T ,R
• Type of Device: SURLOK HELICAL STONE BASKET
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8463272
• MDR Text Key: 141353030
• Report Number: 2951238-2019-00584
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

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
• Device Operator: Health Professional
• Device Model Number: 5700006
• Device Lot Number: MK715070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 06/18/2019; 04/23/2019
• Supplement Dates FDA Received: 07/16/2019; 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 78