MAUDE Adverse Event Report: GYRUS ACMI, INC SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-PLS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone number: (b)(6).The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported an unspecified time after a uretero-renoscopy (urs) procedure (to treat pelvic calculi) using a soltive premium superpulsed laser system, the patient developed ureteral stenosis.A ureteral dilation procedure was performed to treat the stenosis.The laser settings used for this procedure were: 10:09 am, 3:51 mm:ss, 23103, 4.621 kj, 20 w, 100 hz, s 033020-1259, 150s.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.This facility reports eight cases in which the ureteral stenosis has occurred after a urs procedure using this laser machine (out of 180 procedures performed with this laser).The facility reports not all of these cases of ureteral stenosis were due to the soltive laser alone, some patients had large or long-standing stones in the ureter.Case with patient identifier (b)(6).
Event or Problem Description
New information provided by the customer: size of stone: 9mm.Location of stone: pelvis.Stenosis length: 5 (unit of measure not provided).The patient experienced an ureteral injury with no extravasation treatment also included a nephrostomy.Date stenosis diagnosed: (b)(6) 2021.Outcome after dilation: nephrostomy then re-implantation laser did not malfunction.
Additional Manufacturer Narrative
This report is being updated to report additional information reported by the customer.New information is reported in a2, a3, a3, b5, b7, and d10.D10: concomitant devices urs semi-rigid/urs flexible/urethral sheath ch.10-12/ guide sensor/pigtail7/28/uromax ch 18, 150s laser fiber, lot number: 033020-1259.
Additional Manufacturer Narrative
This report is being updated to report investigation findings.Device history record (dhr)/service history review: a dhr review has been performed for this product and determined that there were no nonconformance's during the manufacturing process of this device.Physical device inspection: the product was not returned, and no pictures have been provided, therefore a physical inspection of the device could not be performed.Evaluation/analysis: the customer was not provided an updated ifu beyond the initial software version 1.0 revision.The laser console has since been updated to software version 2.1.The customer does not appear to have been notified of the field safety corrective action as the unit was not at the customer location up on release of the field safety corrective action which would have also informed them about the changes to the consoles.The customer is currently not using this console and will receive training and an updated ifu upon being willing to use the product again.Conclusion: the oem performed an investigation and is a result of the following information.The oem determined that the most likely factor contributing to the observed clinical outcome was excessively high average power, possibly aggravated by inadequate irrigation.As a result, bulk temperature in the ureter was elevated above safe levels, which, in turn, led to contraction of the passage and ureteral stenosis the manner in which soltive system was employed constitutes misuse, since it directly contradicts recommendations of the device manual provided to the customer with the device (exceeding recommended settings).

• Brand Name: SOLTIVE PREMIUM SUPERPULSED LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12043126
• Report Number: 3003790304-2021-00115
• Device Sequence Number: 10550121
• Product Code: GEX
• UDI-Device Identifier: 00821925044111
• UDI-Public: 00821925044111
• Combination Product (Y/N): N
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFL-PLS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/05/2021; 08/30/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/22/2021; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 100