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

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.

• 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: 14143080
• MDR Text Key: 294640008
• Report Number: 8010047-2022-06630
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• 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
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• 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: 03/22/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male