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

Model Number SPL-T

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported issue of cannot plug the transducer was not confirmed.The device was inspected and tested.All functions and outputs are within the standard specifications.The device passed the functional testing, output and electrical safety test.Minor scratches were found on the housing which unrelated to the reported issue.Once device was completed, the device was placed in the stock inventory.

Event Description

It was reported that device transducer cannot plug into the generator.The plug was found broken.No further details were provided regarding the event.No patient involvement was reported.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr), the device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Evaluation of the returned device determined that the reported complaint could not be confirmed.The device was inspected and tested.All functions and outputs are in standard specifications.The unit passed functional test, output test and electrical safety test.The only abnormality noted was the presence of minor scratches on the housing.A definitive root cause could not be determined on the reported issue.The customer was contacted in attempt to obtain additional information however were unsuccessful.No response was received from the customer.If additional information becomes available at a later date, the complaint will be updated accordingly.Olympus will continue to monitor complaints for this device.

• 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: 10385994
• MDR Text Key: 202985424
• Report Number: 3011050570-2020-00037
• 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: 09/11/2020

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 Number: SPL-T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1