MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-650U

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

Patient Problems Hemorrhage/Bleeding (1888); Shock (2072)

Event Date 03/16/2022

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "propensity score matching analysis to evaluate efficacy of polyethylene oxide adhesive on preventing delayed bleeding after gastric endoscopic submucosal dissection" by yang yu, et al.  regardless of technical advancements, delayed bleeding is still a common adverse event after gastric endoscopic submucosal dissection (esd), often occurring in the early postoperative phase.This study aimed to evaluate the efficacy of a newly designed polyethylene oxide (peo) adhesive for preventing delayed gastric bleeding.Patients who underwent gastric esd between (b)(6) 2017 and (b)(6) 2020 at three chinese institutions were retrospectively reviewed.Patients receiving peo application on gastric post-esd ulcers were included in the peo group, and patients without this procedure were included in the control group.To minimize potential bias, propensity score matching was performed, and sex, age, lesion size, lesion morphology, ulceration, localization, procedure time, frequency of major intraoperative bleeding, resected specimen size, lesion histopathology, submucosal invasion and the taking of antithrombotic drugs were included as matching factors.The incidence of delayed bleeding and time to bleeding were compared between both groups.After propensity score matching, 270 patients (135 per group) were included in the analysis.The delayed bleeding rate in the peo group was significantly lower than that in the control group (1.5%, 2/135 vs.8.9%, 12/135, p= 0.006).The median time (range) to bleeding was 4.5 (4¿5) days in the peo group and 2 (1¿15) days in the control group, with no significant difference (p= 0.198).Peo demonstrated a significant effect in reducing the rate of delayed bleeding.Further study is warranted to confirm the efficacy of peo for bleeding that occurs in the early phase after gastric esd.Adverse events: n = 1 experienced haemorrhagic shock on pod1 with transient tachycardia and hypotension, and he also received a blood transfusion because of a decrease in haemoglobin from 101 to 62 g/l.After endoscopic haemostasis and conventional medical treatment, the patient¿s condition stabilized on the same day, and he was discharged on.N = >14 - for patients with delayed bleeding, endoscopic haemostasis was successfully performed primarily with electrocoagulation for all bleeding sites.Metal clips were used as combined therapy for 5 lesions.Immediate haemostasis was achieved in all cases, and no re-bleeding events occurred later.N= 4: major intraoperative bleeding was arteriolar bleeding or diffuse venous bleeding in which haemorrhagic sites could not be located for the first time.The article includes 6 reports: patient identifier (b)(6): kd-650u.Patient identifier (b)(6): gif-hq290.Patient identifier (b)(6): ucr.Patient identifier (b)(6): fd-411ur.Patient identifier (b)(6): nm-200l-0423.Patient identifier (b)(6): gif-q260j.This report is 1 of 6 for patient identifier (b)(6): kd-650u.

Manufacturer Narrative

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.

Event Description

Additional information received from the author: the author stated the olympus device did not cause or contribute to the adverse events reported.He also reported: the image blurring during the operation had nothing to do with our machine.The haemostatic powder used in the literature was sticky, which stuck to the ccd glass of our endoscope during esd surgery, causing temporary image blurring.These problems were determined by the haemostatic powder provided by other manufacturers.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author.New information added to b5.

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.Additional information added to b3 and g2.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14103863
• MDR Text Key: 294495845
• Report Number: 8010047-2022-06213
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265785
• UDI-Public: 04953170265785
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650U
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SERIAL/LOTS UNKNOWN:GIF-HQ290,UCR,FD-411UR.; SERIAL/LOTS UNKNOWN:NM-200L-0423,GIF-Q260J.
• Patient Outcome(s): Required Intervention; Other