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 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.

• 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 Key: 9317309
• MDR Text Key: 204563656
• Report Number: 2951238-2019-01186
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• 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 Number: SPL-PDBX376
• Device Lot Number: D1901220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/13/2019
• 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 Number: 1
• Patient Age: 57 YR
• Patient Weight: 119