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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 10/21/2019
Event Type  malfunction  
Manufacturer Narrative
The returned shockpulse probe (lot#d1908749) was evaluated for ¿probe broke¿ issue.The reported complaint was confirmed.The returned probe is received broken in two pieces.Visual inspection determined that there was biomaterial inside the tube and found scratches on the nose cone consistent with use.The probe is broken close to the proximal side, the distance measured approximately 65 mm from the nose cone.The damaged area is inspected under the microscope revealing some deep scrapes and scratch marks on the working tube.The jagged edges of both tubes were aligned indicating no missing fragments.Functional testing was not performed as the device was broken when received.In summary, based on the evaluation and investigation results, the likely root cause of the physical damage found on the probe was due to the unit being struck against another hard object and due to mishandling.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 lithotripsy procedure probe broke / stopped working.The device was removed from the patient.When the user unscrewed the nose cone, it was found that the probe was snapped off.There was no patient harm or injury reported due to the event.
 
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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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key9317309
MDR Text Key204563656
Report Number2951238-2019-01186
Device Sequence Number1
Product Code FEO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 11/13/2019
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 NumberD1901220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/25/2019
Initial Date FDA Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age57 YR
Patient Weight119
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