MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PDBX340

Device Problem Break (1069)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.The evaluation found the probe was broken at the proximal end site.The tube was also deformed.The investigation is ongoing.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the shockpulse probe single use, 3.40mm 3/bx, broke during a procedure.Per the customer, the probe was made ready and tested before it came in contact with the patient.After 5-10 seconds of use there was a strange sound and the probe broke.The hospital used a similar probe to finish the procedure.There was no harm to the patient or user.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the correction in d9 and the updates in sections h4, h6, and h10.Correction to g3 of the initial medwatch.The aware date should be 24-mar-2022.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely the damage to the probe occurred due to excessive force being applied to the device.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

D4 unique device identifier (udi): (b)(4).

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX
• 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: 16219254
• MDR Text Key: 308026033
• Report Number: 3005975494-2023-00015
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2023

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-PDBX340
• Device Lot Number: KR176789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 01/23/2023; 01/28/2023; 05/01/2023
• Supplement Dates FDA Received: 01/24/2023; 02/16/2023; 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1