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

Model Number SPL-T

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.Upon evaluation of the returned device it was noted that the suction outlet at the proximal end of the transducer was damaged.As this device is non-serviceable, the device was returned unrepaired.Device history record review was completed and records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.This is a known failure mode and may be attributed to user mishandling or improper reprocessing.Per the device ifu (spl-ifu rev am), the transducer is validated for only 100 reuses.Damage may result if cleaning and reprocessing is not performed according to ifu instruction.Per the ifu, "caution after each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for tears, cracks or other signs of damage.Never use damaged equipment.This product is not validated for high-level disinfection.".

Event Description

The user facility returned the device for an unspecified failure.There was no patient involvement reported.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 10379126
• MDR Text Key: 219547828
• Report Number: 3011050570-2020-00031
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1