MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problems Corroded (1131); Incomplete or Inadequate Connection (4037)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The evaluation confirmed the user report.The unit failed and was pulled out from the generator without having to press on the connector end.In addition, corrosion was found on the metal thread of the connector on the probe side.This event is under investigation.A supplemental report will be submitted upon completion of the investigation.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

It was reported that during preparation for use the shockpulse lithotripsy transducer was not working properly.No patient involvement or impact to patient care was reported.

Manufacturer Narrative

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.Please see the updates in sections: g3, g6, h2, and h10.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11252060
• MDR Text Key: 250462256
• Report Number: 3011050570-2021-00037
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 821925043831
• 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: 03/01/2021

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: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1