MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VH

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

Patient Problems Aneurysm (1708); Cardiac Arrest (1762); Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888); Hypoxia (1918); Ischemia (1942); Necrosis (1971); Septic Shock (2068); Rupture (2208); Respiratory Failure (2484); Ascites (2596); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Increased Intra-Peritoneal Volume (IIPV) (4498); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Date 02/27/2024

Event Type  Death  

Event Description

It was reported during a percutaneous nephrolithotomy (pcnl) procedure the cysto-nephro videoscope had no flow out of the outer sheath resulting in increased intrarenal pressure causing complications.When an olympus representative was onsite at the customer, they were informed that after the pcnl procedure the patient had additional surgeries (not specified) and ended up passing away.Additional information was requested from the customer, but not provided.

Manufacturer Narrative

Three attempts were performed to obtain additional information, but no response was received from the customer.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide an update to field h4.The device history record 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.Based on the results of the investigation, the subject device was not returned, and a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental is being submitted to include additional information regarding the patient, the event, and the device received from the customer.The legal manufacturer's investigation was reopened due to the updated device information.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following patient identifiers: (b)(6).This report has been submitted by the importer under this mdr report number 2429304 - 2024 - 00210.

Event Description

Additional information regarding the event and device was received by the customer: it was reported during a percutaneous nephrolithotomy (pcnl) procedure, there was no flow out of the outer sheath resulting in increased intrarenal pressure causing complications.When an olympus representative was onsite at the customer, they were informed that after the pcnl procedure the patient had additional surgeries and ended up passing away.The patient was initially diagnosed with a 4-centimeter obstructive left pelvic staghorn calculus with chronic hydronephrosis and renal cortical thinning with multiple non-obstructive left renal calyceal calculi.The patient had marginal kidney function at 20%.The patient did not want to lose her kidney.The surgeon discussed options with the patient and informed her that she would likely lose the kidney in the future, but they decided "to give this procedure a try".On (b)(6) 2024 the patient underwent a percutaneous nephrolithotomy (pcnl) procedure using an olympus mini-pcnl tray with mini nephroscope.During the procedure, it was reported that there was not enough outflow from the working sheath and there was poor visualization.Several attempts were made to switch the irrigation port and test for possible continuous flow, but they were unsuccessful.As a final solution, the nephroscope was removed intermittently to let the irrigation drain out.The surgery was continued, and the stone was broken completely with a large bore laser.The surgeon noted later in the case that we he pulled the scope out he was no longer getting fluid backflow.When he realized he was no long getting flow out, even when the scope was removed, he decided to place stents, stop the procedure, and perform the rest of the procedure at another time.When attempting to place the stent, it was noted that the patient seemed to have developed ascites.The patient remained stable per the anesthesiologist and the surgeon decided to put a drain in the abdomen under ultrasound guidance.About 1 liter of fluid came out of the drain.An urgent computed tomography (ct) scan was performed which showed rupture of the lower kidney and oozing from around the kidney.They attempted to stabilize the patient in the intensive care unit (icu), and subsequently took the patient emergently to perform a nephrectomy.Five subsequent surgeries were also performed in the next 48 hours.The dates and additional surgeries the patient underwent are as follows: on (b)(6) 2024 - exploratory laparotomy, open left nephrectomy, source control, packing and would vac.On (b)(6) 2024 - re-exploratory laparotomy, transverse and descending colon resection, 6 laparotomy sponges packs, abdominal negative pressure would therapy placement, laparotomy exploratory, left oophorectomy.On (b)(6) 2024 - re-exploratory laparotomy, right ascending colostomy, left mucous fistula, 6 laparotomy sponges packed, abdominal negative pressure wound therapy placement, laparotomy exploratory, left oophorectomy.On (b)(6) 2024 - removal of right chest tube and placement of new right chest tube, left brachial artery thrombectomy, left distal ulnar artery thrombectomy, intraoperative left upper extremity angiogram, left forearm volar fasciotomy, embolectomy brachial artery, brachial thrombectomy/left leg fasciotomy/ulnar thrombectomy/intraoperative cholangiogram, fasciotomy lower extremity.During the icu admission, the patient additionally had an ultrasound placement of intraperitoneal drain, echocardiogram, x-rays, ct scans, interventional radiology, and cardiopulmonary resuscitation (cpr).The patient experienced the following additional complications: intraperitoneal fluid collection, hypoxia, abdominal compartment syndrome (likely due to pyelocaliceal injury and fluid extravasation), hemorrhage, disseminated intravascular coagulation (dic), dissection of the distal aorta, necrotic transverse and descending colon, intrarenal abdominal aortic aneurysm without rupture, and right lower extremity (rle) critical limb ischemia, injury of lumbar branches of the aorta, septic shock, and cardiac arrest.The patient died two days post procedure.The cause of the patient's death was attributed to cardiac arrest, septic shock, colon ischemia, disseminated intravascular coagulation (dic), hemorrhagic shock, respiratory failure, kidney stone, abdominal compartment syndrome, deep vein thrombosis (dvt), and parenchymal rupture of the kidney.An autopsy was not performed.During follow-up with the performing surgeon, it was noted that he had requested the hospital obtain non-olympus sheaths of different sizes, but the hospital had only one size available that he did not want to use as he did not want to dilate the patient to 30.The surgeon remembered olympus had a dilator and metal sheaths with gauges of 18f and 20f that were compatible with the mini pcnl device, and they decided to "give it a shot".During a root cause analysis, the surgeon concluded that if he had done a normal pcnl this incident could have been prevented.He stated that the numbers that are provided by olympus for their sheath gauges are 18f and 20f and that number represents the outer diameter of the sheath, not the inner diameter of the sheath.Additionally, he stated if you compare these measurements to a non-olympus sheath, the number provided represents the inner diameter of the sheath, not the outer diameter.Urologists are used to one number on their sheaths and that is the inner diameter not the outer diameter.Since this event, the surgeon noted that the olympus metal sheaths were removed from use, and from this point forward he will use the non-olympus sheaths in sizes that he is comfortable with to perform procedure.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; odakura, nishigo-mura,; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18997063
• MDR Text Key: 338844130
• Report Number: 3002808148-2024-02971
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/11/2024
• Supplement Dates FDA Received: 04/15/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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
• Treatment: A37022A (LOT # 23801); WA2PS20L (LOT # 152474); WA2PS20S (LOT # 152424)
• Patient Outcome(s): Death; Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 90 KG