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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the device could not be inserted into the generator¿s port at the front due to damage.It had a broken piece.

Event Description

As reported for this event, during set up for an unknown therapeutic procedure the device would not plug in into the generator.There is no patient involvement, and no harm reported to any patient.

Manufacturer Narrative

Correction is being made to g3; adding company representative to the report source.Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Initial reporter job title is ap equipment specialist.The plug would not line up with the generator.The device has been replaced as it was not repairable per olympus.This was the only issue with this device.There were no other issues with any other devices.There were no alarms.The date this occurred on is unknown.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h6, and h10.The spl-t transducer, serial (b)(6), was returned to olympus with the user's request that "the device will not plug into a generator." physical evaluation of the received device confirmed the user¿s complaint as the transducer plug was found to be damaged with broken pieces.This damage caused the transducer unable to plug into a generator.Device history records were reviewed and showed the product met all specifications upon release.Based on device inspection results, damage to transducer plug is most likely caused by improper handling.The instructions for use (ifu) states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." (warnings and cautions, page 1).

• 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: 10726946
• MDR Text Key: 212767247
• Report Number: 3011050570-2020-00124
• 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,Followup
• Report Date: 01/06/2021

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: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/27/2020; 12/15/2020
• Supplement Dates FDA Received: 11/18/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1