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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that the suction cone was chipped.There were no reports of patient harm.

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem was confirmed.The device evaluation found a broken suction port.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer and completion of investigation.Please see updates to b5,d4, h6 and h10.Based on the investigation, it is likely that the suction port damage occurred accidentally during device reprocessing due to improper handling of the device.However, the root cause of the complaint could not be conclusively determined.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.To prevent device damage and or patient injury, the instruction for use provides the following: ¿ properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.¿ visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches.¿ visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).¿ impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.¿ if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.Olympus will continue to monitor the field performance of this device.

Event Description

Update from customer: the issue was found after reprocessing.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17436724
• MDR Text Key: 320340469
• Report Number: 3011050570-2023-00102
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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: 07/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 08/18/2023
• 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