MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

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 therapeutic lithotripsy bladder stone removal procedure, the device tip broke off from the proximal part.The part fell off outside the patient.The user changed the tip and the intended procedure was completed.There was no patient harm or injury reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the reported issue was not identified.The subject device was not made available for evaluation and a definitive root cause could not be determined.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) and as a preventive measure, 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.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10631516
• MDR Text Key: 219549106
• Report Number: 3011050570-2020-00095
• 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: 12/16/2020

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-PDBX340
• Device Lot Number: PW306028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1