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

Model Number SPL-PDBX376

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The device is being shipped to olympus, us for further evaluation and investigation.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 stone removal procedure, the device probe broke off and fell into the patient.The fragments of the broken probe were removed from the patient.There was no patient injury or harm reported.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), device evaluation and investigation conclusion.Device evaluation determined that the reported issue was confirmed.The probe is fractured approximately 10.5 inches from the distal tip.Inspection under magnification noted evidence of contact wear with the nephroscope near the location of the fracture.Scratches and deep scrapes are present in addition to chipping at the fracture plane.Review of dhr 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.

• 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: 10815964
• MDR Text Key: 215485072
• Report Number: 3011050570-2020-00142
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPL-PDBX376
• Device Lot Number: D1808097
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1