MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX376

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

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 an unspecified procedure the device probe broke, cracked where the probe meets the transducer.The device was being used for approximately 3 seconds when the device broke.The user used another probe, and the intended procedure was completed with no issues observed.No known device fragments fell into the patient.No patient harm was reported due to the event.No user injury reported.

Event Description

The malfunction occurred during the first minute or two of a percutaneous nephrolithotomy (pcnl) therapeutic procedure.There were no other devices involved in the event.There was a delay of a few minutes to obtain and attach a new probe.The procedure was completed with this similar device.

Manufacturer Narrative

This supplemental report is being submitted to provide the customer response and updates.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number , device evaluation and investigation conclusion.Device evaluation confirmed the reported issue.Device inspection observed that the probe broke at the proximal end near braze joint.In addition, rust on the probe threads was observed.There were no signs of the coating coming off the probe.Dhrs 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.The root cause of rust on the threads cannot be determined at this time.The device ifu advises users to thoroughly inspect all electrical cables and probes before each use.Do not use if there is any evidence of deterioration.Replace if any damage or excessive wear is observed.Olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10828529
• MDR Text Key: 216693382
• Report Number: 3011050570-2020-00145
• 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,health
• 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-PDBX376
• Device Lot Number: KR886409
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/12/2020; 01/18/2021
• Supplement Dates FDA Received: 12/08/2020; 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1