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 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation, however, a picture of the damaged device indicates the probe's black coated shaft was broken at the middle area.The exact cause of the reported event could not be confirmed.The device history record (dhr0 for the concerned device has been reviewed.All records indicate that the device 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 the reported lot number with no associated non-conformities, reported scrap or recorded process deviations.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that during a percutaneous nephrolithotomy (pcnl) procedure, the middle portion of the probe's shaft broke while inside the patient.The user was able to retrieve the broken probe when the scope was withdrawn.The intended procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

To date, the device was not returned.Based on photo the reported.The device history records for the concerned device has been reviewed.All records indicate that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of (b)(4) were produced under this lot number with no associated non-conformances or process deviations relating to the reported failure.A review of the complaint database revealed no additional complaints attributed to this lot number.The type of failure observed in the photo was consistent with misuse.If excessive torque was applied to the device during activation the probe could snap near the nephroscope's instrument port.Per shockpulse system instruction manual, "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." based upon a review of production documentation and complaint history, there was no indication of systemic failure across this lot of devices.The reported failure can likely be attributed to misuse.If the device becomes available at a later date this report will be supplemented accordingly.

• 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: 9530152
• MDR Text Key: 198552283
• Report Number: 2951238-2019-01238
• 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
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-PR340
• Device Lot Number: D1908847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1