MAUDE Adverse Event Report: GYRUS ACMI, INC SRLK,FLTW,3.0,4W,20,090,O T,R

Model Number 5710006

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

The customer returned a 5710006 flatwire basket device for evaluation.The device was returned in the original tray with a tyvek lid attached.Upon evaluation of the returned device, it was noted that the complaint was inaccurately reported, ¿sheath became detached from the handle during the procedure causing the sheath to slip over the wire shaft of the basket.¿ the device was returned with sheath anchored in place and the basket assembly detached and no longer secured to the collet inside the handle assembly.Further visual inspection found a kink in the basket assembly approximately located 14 inches from the distal tip.It is likely that the kink was incurred during use and in the action of attempting to overcome the kink or a related obstruction, excessive force was applied and the basket slipped from the collet inside the handle.All components inside the handle, including the collet, are intact.The device history records for this product were 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 nonconformance, reported scrap or recorded process deviations relating to the reported failure.Based upon evaluation of the returned device and production records, there is no indication that manufacturing attributed to the reported failure.The same customer has registered one additional complaint for this lot.That device failed in the same manner with a similar kink present, suggesting the failure of the device is use related.The legal manufacturer will continue to monitor complaints for this device through regular trending activities.

Event Description

The service center was informed that during an ureteroscopy procedure, the sheath from two devices became detached from the handle causing, the sheath to slip over the wire shaft of the baskets.In each instance, the doctor had opened the baskets inside of the patient to retrieve the stones and upon removal, the sheath detached.The sheath did not fall into the patient.The procedure was completed with a similar device from a different lot.There was no patient injury reported.Additionally, it was reported that the device was inspected prior to use and no damage or abnormalities were observed.The devices are being stored in a cabinet with no more than four stacked on top of each other in the room.The back-up devices are being stored in a rubbermaid container with a lid on them.This report 2 of 2.

• Brand Name: SRLK,FLTW,3.0,4W,20,090,O T,R
• Type of Device: SRLK,FLTW,3.0,4W
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 10076588
• MDR Text Key: 216922732
• Report Number: 3011050570-2020-00007
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5710006
• Device Lot Number: KR844819
• 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: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 89