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 Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device in question has been returned to (b)(4) site and is on the way to olympus for evaluation.The analysis of the device is not yet available and the cause of the reported event cannot be determined at this time.A supplemental report will be filed when the product investigation has been completed.Per the shockpulse-se lithotripsy system instructions for use, ¿if a probe breaks during a procedure, use a grasping device to remove it.Always have a spare probe set available to finish the procedure¿.

Event Description

It was reported that during a pcnl (percutaneous nephrolithotomy) procedure, the device probe broke in the middle of the case.No device pieces fell into the patient and there was no bleeding reported.The intended procedure was completed using a new probe.There was no patient harm or injury reported due to the event.

Manufacturer Narrative

The spl-pdbx376 shockpulse lithotripsy probe was returned for evaluation.Evaluation of the returned device noted that the probe was fractured near the proximal end, approximately 17 inches from the distal tip.All components were returned and no fragments are missing.The reported failure was likely cause by application of excessive force and/or torque during activation.Fracture near the threaded connector, as in this case, is consistent with this failure mode.Per the device ifu, "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.A back-up transducer and probe should be sterilized and available prior to beginning a procedure." the probe must be held concentric with the scope's luemen while activated.Excessive use of the device or torquing the probe during use can increase the occurrence of probe failures.The dhrs for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 120 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.Based upon evaluation of the returned device and review of manufacturing records, damage to the shockpulse probe likely occurred during use as a result of the application of excessive force and/or the application of torque against the scope's luemen.

• 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: 9323750
• MDR Text Key: 199320057
• Report Number: 2951238-2019-01187
• 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: 02/13/2020

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-PDBX376
• Device Lot Number: D1901195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/05/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1