MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PR340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Device was returned to the olympus (b)(4) site.Photos of the subject device were provided.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a therapeutic pcnl (percutaneous nephrolithotomy ) procedure the device probe broke at the shaft where the probe meet the pcnl scope.The user stopped the procedure immediately to remove the broken unit from their scope.The user checked for any fragments and found out it was a clean break and no fragments from the broken unit were found inside or outside of the patient.The intended procedure was completed using similar device.The serial number used was not provided.There was no patient injury reported.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), device evaluation (photos provided) and investigation conclusion.Review of the photos provided by olympus malaysia, the reported issue was confirmed.The photos show that the shaft breakage occurred close to the proximal end, and the fracture surfaces are relatively regular or even.Contact wear on the shaft surface near the facture was also observed.Dhr review 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.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.As stated on the ifu (instruction for use) the user manual states: 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.

Manufacturer Narrative

This supplemental report is being submitted to provide customer response and updates.This is a non-serviceable device and disposition is to dispose the unit.No physical unit return to mbc( manufacturing business center).If additional information becomes available this report will be supplemented accordingly following investigation.

Event Description

Updates on the event reported: the issue occurred at the beginning of the procedure.There was a delay in the procedure to inspect the breakage and to change the probe.A richard wolf pcnl scope was involved in the event.Shockpulse probe 3.4mm spl-or340 (d1909043) was the device used to complete the procedure.

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11055242
• MDR Text Key: 240385494
• Report Number: 3011050570-2020-00187
• 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
• Report Date: 01/25/2021

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: Health Professional
• Device Model Number: SPL-PR340
• Device Lot Number: D1909043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 01/20/2021
• Supplement Dates FDA Received: 01/20/2021; 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1