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

Model Number SPL-PR376

Device Problem Break (1069)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

Olympus reviewed the following literature titled "comparison of swiss lithoclast® trilogy and shockpulse-se as energy source in percutaneous nephrolithotomy for staghorn stones: a matched pair analysis." this study aimed to evaluate efficacy of swiss lithoclast trilogy (boston scientific, usa) and shockpulse-se (olympus) in pcnl for staghorn stones in 85 patients.Trilogy had 81.48 % clearance and shockpulse-se had 61.53% clearance at 48 hours in first stage pcnl.18.51% patients of trilogy and 38.46% patients of shockpulse-se required subsequent staged pcnl.Trilogy had 92.59% stone free rate at 3-month follow-up while shockpulse-se had 80.76% stone free rate.As per the study results, trilogy has comparable stone fragmentation rate with shockpulse-se in managing staghorn renal stones.Complications and instrument malfunction were also comparable for trilogy and shockpulse-s.Type of adverse events/number of patients: clavien-dindo grade-ii complications -3 (uti with fever).Malfunctions: suction block - 2, probe breaks - 3.This literature article requires 6 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for patient identifier (b)(6).

Manufacturer Narrative

Since the literature described "shockpulse-se", olympus selected "spl-pr376" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article doi: 10.1089/end.2022.36001.Abstracts provided for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the corrections in e4 and g2 and the updates in h6 and h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.Since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The following information is stated in the instructions for use (ifu): ¿page 22 of shockpulse instructions for use (spl-ifu_an) states, "the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance."¿ olympus will continue to monitor field performance for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,
• 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: 16132896
• MDR Text Key: 308737363
• Report Number: 3011050570-2023-00011
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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-PR376
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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