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 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation however, a photo of the unit was provided to olympus.The user facility was requested to return the device (broken probe) for complete evaluation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a pcnl (percutaneous nephrolithotomy) case, approximately more than half way (3/4) in the procedure, the user was using the probe and felt like it was not doing anything anymore.The user pulled the probe out and part of the shaft was still inside the patient.The user removed the broken piece inside the patient using a grasper.A new probe was used and the intended procedure was completed.The serial/lot number of the probe used to complete the procedure was not provide.There was no patient harm or injury reported.No user injury or harm reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.Please see updated sections: d4, d10, g4, g7, h2, h3, h4, h6 and h10.Physical evaluation of the received device confirmed that the probe was fractured approximately 10.375 inches from the distal tip.Signs of wear from the nephroscope was noted.Scrapes were also observed approximately 1 inch distal to the fracture and 0.0125 inches proximally.All dhr records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The reported failure is most likely a result of additional torque being placed on the probe during use.Probe is prone to wear and resultant fracture if the user does not hold it concentric to the instrument channel of the nephroscope during use.The ifu (instruction for use) advises that "the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.Do not allow the probe to press against the scope during the procedure".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: 10595965
• MDR Text Key: 208835857
• Report Number: 3011050570-2020-00088
• 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: 01/18/2021

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: D1800967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1