MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PR150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a ureterostomy (urs) procedure the device probe broke.The patient was under anesthesia at the time of the event.The intended procedure was completed using another similar device.No patient injury or harm was reported due to the event.No user injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the customer response and updates.Photo of the subject device was provided for evaluation.If additional information becomes available this report will be supplemented accordingly.

Event Description

Updated information : probe broke during one procedure only, not two.The procedure performed was a rirs puj (pelvic ureteric junction) stone case used with 8 fr wolf semi rigid ureteroscope.There was a delay in the procedure approximately 5 minutes with no harm to the patient.Intended procedure was completed with a back up similar device.

Manufacturer Narrative

This supplemental report is being submitted to provide updates on device model.Spl-sr' updated to 'spl-pr150 in section d4.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The subject device was not made available to olympus for evaluation.Upon review of provided photos, the complaint was confirmed.The probe fracture near the braze joint at the proximal end of the device, distal to the threaded connector.Review of device history records (dhr) records showed that all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on available information, a definitive root cause of the reported complaint cannot be determined.However, fracture of the probe is often a result of user mishandling during use.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.Per ifu(instruction for use) : the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10787886
• MDR Text Key: 214645339
• Report Number: 3011050570-2020-00137
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• 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: 02/03/2021

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: Other
• Device Model Number: SPL-PR150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 12/09/2020; 01/27/2021
• Supplement Dates FDA Received: 12/08/2020; 12/09/2020; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8FR WOLF URETEROSCOPE.; 8FR WOLF URETEROSCOPE
• Patient Age: 51 YR
• Patient Weight: 60