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

The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and found the tip is broken and there is a damaged transducer plug.The item was found to be unrepairable.The device was returned to the user facility.

Event Description

The user facility reported that there is a problem with a probe that is broken at the proximal end.The tip is broken.There was no patient involvement.No additional information was provided.

Event Description

The customer also reported that the issue was with the transducer plug and not the actual probe.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information to clarify which device had the broken tip.According to estimation, the customer did not send their probe back with their transducer.When estimation confirmed that the tip was damaged, they were referring to the transducer plug, which was damaged near the o-ring.Because of the damage, the transducer was unable to connect the generator (spl-s) receptacle.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.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.Based on available information, a probable cause of the found failure cannot be determined.However, damage to transducer plug is often incurred as a result of user error.This product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage as stated on the ifu (instruction for use) and as a preventive measure, the user manual states: connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.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: 10284020
• MDR Text Key: 219549115
• Report Number: 3011050570-2020-00020
• 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: 01/18/2021

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: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 01/11/2021
• Supplement Dates FDA Received: 09/29/2020; 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1