MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/01/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "real-life indications and outcome of electrocautery-enhanced lumen-apposing metal stents in a tertiary center".Literature summary purpose: electrocautery-enhanced lumen-apposing stents (ec-lams) were originally designed for the drainage of the gallbladder, bile duct, and pancreas pseudocysts.Throughout the years, several off-label indications were established.This study aims to evaluate the indication, safety, efficacy, and outcome of all lams implanted in a single tertiary referral center.Methods: from april 2016 to april 2022, all patients undergoing lams placement in a single tertiary center were included.We present a detailed analysis of indications, success rates, and complications based on a retrospective analysis of our prospectively maintained database.Results: a total of 86 stents were placed in 77 patients between april 2016 and april 2022.Indications were walled-off pancreatic necrosis (25.6%), bile duct obstructions (16.3%), acute cholecystitis (15.1%), pancreas pseudocysts (15.1%), postoperative collections (10.5%), postoperative pancreatic fistulas (9.3%), and gastro-gastrostomy/jejunostomy (8.1%) to enable to perform an endoscopic retrograde cholangiopancreatography in patients with gastric bypass.Technical success was 97.7% (84 out of 86).A total of 10 (11.7%) adverse events were observed.In 3 patients (3.5%), severe complications occurred, which required acute surgery; one displacement was closed through clips.In 7 patients (8.2%), bleedings occurred during necrosectomy or from mucosal erosions at the stent side, respectively, that were treated with endoclips.Conclusions: (electrocautery-enhanced lumen-apposing stents (ec-lamss) are safe and show a high technical success rate in all indications.In everyday clinical practice, the main indications are hepato-pancreato-biliary, and therefore an hepato-pan-creato-biliary-surgical department should have ec-lams in their armamentarium.Type of adverse events/number of patients event1: bleeding during necrosectomy (1).Event2: bleeding after implantation of the stent (1).Event3: bleeding by mucosal erosion from the stent (5).Event4: perforation (2).Event5: dislocation (1).Event6: acute cholecistitis (1).Event7: acute abdomen (1).Event8: deaths (2).Bleeding in seven patients were observed during necrosectomy, after implantation of the stent and mucosal erosion from the stent.Perforation was observed in two patients and dislocation in one patient that required intervention to close with hemostatic clips.Post-procedural adverse events were observed after the implantation of the stent, one day after the intervention, there was a rapid clinical deterioration, and the patient presented with an acute abdomen requiring laparotomy.Minor arterial bleeding was found next to the stent site, originating from a small arterial vessel of the pancreatic parenchyma.The bleeding was stopped with a monopolar electrocautery, the stent was removed, and the hole in the stomach was sewn up.The patient was asymptomatic afterward.However, the same patient developed a recurrent peri-pancreatic retention and another hotaxios stent was placed 3 months later without any complication.In another patient, a lams was placed to perform a gastro-gastrostomy to gain access for performing an ercp after gastric bypass.Six days after the uncomplicated implantation, the stent dislocated while attempting to move the duodenoscope through the stent into the duodenum, leaving both lumina, the gastric pouch, and the gastric remnant open to the abdominal cavity.An immediate laparotomy with extraction of the stent and suturing of the perforation was performed.Choledocholithiasis was removed by performing a choledochotomy and t-tube.Four patients had a second pseudocyst, which was drained by a second hotaxios stent, 2 patients developed a recurrent pseudocyst about 1 year after extraction of the initial stent.Two patients had a hotaxios placed for different indications, creation of a choledocho-duodenostomy and drainage of a pseudocyst.In 1 patient, a stent was placed due to postoperative retention following partial pancreatic resection due to metastasis in the head of the pancreas of choroidal melanoma.The patient developed an acute cholecystitis, and a second hotaxios was implanted to drain the gallbladder.Also, ¿buried stent¿ was obsrved this syndrome describes lams embedded within overgrown mucosa.Closure of the lams implantation site was performed with 2 clips (olympus hemostatic clip hx-610-090l) on the duodenal site and healed without further complications.In 1 patient, no treatment was needed, 2 patients required 2 and 3 gastroscopies, respectively, with clip placement (olympus hemostatic clip hx-610-090l) to stop the bleeding.In 1 patient, bleeding was observed from the necrotic cavity after stent implantation.Olympus hemostatic clip hx-610-090l were placed to stop the bleeding.Bleeding control was sufficient in all cases.This literature article requires 6 reports.The related patient identifiers are as follows: 1) patient identifier # (b)(6) , single use retrieval basket fg-v422pr, sn-unk.2) patient identifier # (b)(6), single use retrieval basket, fg-v422pr, sn-unk.3) patient identifier # (b)(6), evis exera ii ultrasound gastrovideoscope, gf-uct180, sn-unk.4) patient identifier # (b)(6), evis exera ii ultrasound gastrovideoscope, gf-uct180, sn-unk (this report).5) patient identifier # (b)(6), ultrasonic gastrovideoscope, gf-uct140-al5, sn-unk.6) patient identifier # (b)(6), ultrasonic gastrovideoscope, gf-uct140-al5, sn-unk.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

H6 codes: heath effect clinical code: dislocation, acute cholecystis and acute abdomen.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached 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.The device history record was unable to be reviewed for this device since the serial and/or 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.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18543842
• MDR Text Key: 333314226
• Report Number: 3002808148-2024-00587
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356339
• UDI-Public: 04953170356339
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• 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
• Removal/Correction Number: Z-0333-2024
• Patient Sequence Number: 1
• Treatment: OLYMPUS HEMOSTATIC CLIP HX-610-090L; SINGLE USE RETRIEVAL BASKET FG-V422PR, SN-UNK; ULTRASONIC GASTROVIDEOSCOPE, GF-UCT140-AL5, SN-UNK
• Patient Outcome(s): Required Intervention