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U.S. Department of Health and Human Services

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

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GYRUS ACMI INC SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX; LITHOTRIPTOR, ULTRASONIC Back to Search Results
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.
 
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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 Key9323750
MDR Text Key199320057
Report Number2951238-2019-01187
Device Sequence Number1
Product Code FEO
Combination Product (y/n)N
PMA/PMN Number
K142428
Number of Events Reported1
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 NumberSPL-PDBX376
Device Lot NumberD1901195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/05/2019
Initial Date FDA Received11/14/2019
Supplement Dates Manufacturer Received01/14/2020
Supplement Dates FDA Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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