MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

Concomitant device: stiff shaft wire, rigid nephroscope, 10fr nephrostomy tube the device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the study literature titled ¿comparison of cost-effectiveness and postoperative outcomes following integration of a stiff shaft glidewire (ssgw) into percutaneous nephrolithotripsy¿ appearing in therapeutic advances in urology, 2021, vol.13: 1-6, patients experienced adverse effects during/after procedures using shockpulse stone eliminator.Case with patient identifier (b)(6) reports a patient in the sswg group experiencing a pneumothorax requiring a chest tube.Case with patient identifier (b)(6) reports a patient in the sswg group experiencing persistent nephrocutaneous fistula requiring a cystoscopy and ureteral stent placement.(this report) study aim: analyze the cost effectiveness of integrating a (ssgw) in percutaneous nephrolithotripsy (pcnl) relative to (st).Method: pcnl involved a hydrophilic glidewire during initial percutaneous access and then two new stiff shaft wires.The ssgw is a hydrophilic wire used for initial access and the remainder of the procedure.Operating room (or) costs were collected for all primary, unilateral pcnl cases over a 5-month period during which st for pcnl was used at a single institution with a single surgeon and compared with a 6-month period during which a ssgw was used.Mean costs for each period were then compared along with stone-free rates and complications.Results: 17 total cases were included in the st group and 22 in the ssgw group.The average operating room supply cost for the st group was $1937.32 and $1559.39 in the ssgw group.The net difference of $377.93 represents a nearly 20% decrease in cost.This difference was statistically significant (p¿=¿0.031).There was no difference in postoperative stone-free rates (82.4% versus 86.4%, p¿=¿1.0, respectively) or complications (23.5% versus 13.6%, p¿=¿0.677, respectively) between st and ssgw groups.Conclusion: transitioning to a ssgw reduced or supply cost by reducing the number of supplies required.The change in wire did not affect stone-free rates or complications.In this case, a patient in the sswg group experienced a clavien dindo grade iiib complication of persistent nephrocutaneous fistula requiring a cystoscopy and ureteral stent placement.There is no report of shockpulse stone eliminator malfunction.No further consequences to the patient have been reported.Additional details regarding the patient and reported event have been requested from the authoring physician.At this time no further information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, no device malfunction was reported.The shockpulse system was unlikely to cause or contribute to the reported complication per medical safety assessment meeting and risk assessment.A definitive root cause cannot be identified.Per shockpulse ifu (instructions for use) rev an, "the shockpulse-se lithotripsy system is intended to be used for fragmentation of urinary tract calculi in the kidney, ureter, and bladder." (intended use, page 7); and "this medical device should be operated only by or under the direct supervision of a physician experienced in ultrasonic lithotripsy procedures." (warnings and cautions, page 7).The shockpulse probe will not be inserted until the targeted stone is viewed.The ifu states, "once the physician visualizes the stone with the endoscope, the appropriate shockpulse-se probe is to slide carefully through the working channel of the nephroscope." (operating instructions, page 28).Olympus will continue to monitor the field performance of this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 12899348
• MDR Text Key: 283494349
• Report Number: 3003790304-2021-00178
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044197
• UDI-Public: 00821925044197
• 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: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Other