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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE Back to Search Results
Model Number KD-620LR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 04/17/2019
Event Type  Injury  
Manufacturer Narrative
Literature states hook knife or insulated tip knife- kd-620lr chosen as the representative device: could be kd-620lr or kd-611l 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.
 
Event Description
It is reported in the literature titled: ¿novel endoscopic treatment strategy for early esophageal cancer in cirrhotic patients with esophageal varices,¿ three patients experienced large bleeding during endoscopic mucosal dissection procedures using olympus devices. Case with patient identifier reports (b)(4) reports the needle knife used in patient procedure 3 of 6; case with patient identifier reports (b)(4) reports the kd-620lr used in patient procedure 3 of 6 ; case with patient identifier reports (b)(4) reports the gf-260j used in patient procedure 3 of 6. Case with patient identifier reports (b)(4) reports the needle knife used in patient procedure 4 of 6; case with patient identifier reports (b)(4) reports the kd-620lr used in patient procedure 4 of 6 ; case with patient identifier reports (b)(4) reports the gf-260j used in patient procedure 4 of 6. Case with patient identifier reports (b)(4) reports the needle knife used in patient procedure 5 of 6 ; case with patient identifier reports (b)(4) reports the kd-620lr used in patient procedure 5 of 6 ; case with patient identifier reports (b)(4) reports the gf-260j used in patient procedure 5 of 6. Study aim: establish a standard treatment strategy for eec in cirrhotic patients with esophageal varices. Method: six cirrhotic patients with early flat type eecs (high grade intraepithelial neoplasia) on or adjacent to esophageal varices were enrolled. Esophageal varix ligation (evl) or trans jugular intrahepatic portosystemic shunt (tips) were used for the initial management of esophageal varices. Follow up endoscopy was performed two months following the initial procedure. Results: the mean longitudinal length of the lesions was 4. 3 cm (range, 2 6 cm). The average procedure time was 72. 8 min (range, 34 135 min) and the average longitudinal length of the resected specimens was 45. 6 mm (range, 30 90 mm). One case had a tumor positive lateral margin with lymphovascular infiltration. Both complete and curative resection rates were 80% (4/5 lesions). Large intraoperative bleeding was detected in patients undergoing evl compared with tips prior to the esd procedure. No severe complications or mortality associated events, including massive postoperative bleeding, perforation, or hepatic failure, were observed. No recurrence and metastasis were observed during the follow up period. Conclusion: the current study suggested a novel treatment strategy for eecs complicated by esophageal varices in cirrhosis with good treatment results, no neoplastic progression and an acceptable adverse event profile. This study investigated a treatment strategy for early esophageal cancers in patients with cirrhosis complicated by esophageal varices. For patients undergoing esd or rfa procedures, the rates of en bloc and complete resections were satisfactory. No severe complications, including postprocedural bleeding or perforation, occurred and the safety profiles were satisfactory, suggesting that esd or rfa could be safely applied for the treatment of early superficial esophageal cancer in patients with cirrhosis complicated by esophageal varices. There is no report of olympus device malfunction described in this study.
 
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Brand NameSINGLE USE ELECTROSURGICAL KNIFE
Type of DeviceSINGLE 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 Key14143184
MDR Text Key294621016
Report Number8010047-2022-06627
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K092309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-620LR
Device Lot NumberUNKNOWN(LITERATURE)
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
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 Treatment Data
Date Received: 04/19/2022 Patient Sequence Number: 1
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