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 Pneumothorax (2012)

Event Type  Injury  

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.(this report) case with patient identifier (b)(6) reports a patient in the sswg group experiencing persistent nephrocutaneous fistula requiring a cystoscopy and ureteral stent placement.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 (b)(6) and (b)(6) in the ssgw group.The net difference of (b)(6) represents a nearly (b)(4) decrease in cost.This difference was statistically significant (b)(6).There was no difference in postoperative stone-free rates ((b)(4) versus (b)(4), (b)(6), respectively) or complications ((b)(4) versus (b)(4), (b)(6), 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 iiia complication of pneumothorax requiring chest tube 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

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.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in d8, h6, and h10.The device history record (dhr) could not be reviewed.No specific model or lot number was provided.Olympus does not ship any device that does not meet all design and safety specifications.The literature did not specify the exact shockpulse model used in the studied cases nor mention device malfunction.No device was available for evaluation.Per shockpulse ifu (instructions for use) "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).Risk assessment was performed and approved by medical safety.It was determined the most likely cause of the reported pneumothorax is related to the creation of the percutaneous access.The process of lithotripsy, and therefore the use of shockpulse (spl) system, is confined to the urinary tract.As the spl is not used to create the percutaneous access, this harm (pneumothorax) is not likely related to the shockpulse 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: 12898911
• MDR Text Key: 286437698
• Report Number: 3003790304-2021-00177
• 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: 01/07/2022

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: 12/13/2021
• 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