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

Model Number SPL-PDBX376

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Inspection of the device confirmed the reported issue.Damaged probe stuck with the transducer horn was observed.Device is non repairable.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.

Event Description

It was reported that the device was found with broken component, debris was observed coming off from the unit, something seems stuck and would not get out.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 11254309
• MDR Text Key: 250462428
• Report Number: 3011050570-2021-00039
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SPL-PDBX376
• Device Lot Number: KR102255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1