MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number KD-655L

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Olympus reviewed the following literature, "endoscopic submucosal dissection of the large intestine using a multi-loop traction device (esd)" by akinari takao, et al.Literature summary: multi-loop traction device (mltd) is tts.It is a traction device that can be delivered by (through the scope), can adjust the traction range and add traction, and is expected to simplify the esd procedure and safely complete esd even in trainees.Is.In our department, colorectal esd is mainly performed by three full-time doctors, one of whom is a trainee (less than 200 cases of colorectal esd).The purpose was to examine the usage, safety and efficacy of mtld in colorectal esd.Kd-655l will be used as a representative product.The authors stated they used one of the two olympus devices (kd-655l and kd-650l) and did not specify which one was involved with the adverse events.Olympus ez clips were also used in the procedure.The clip on the contralateral part of the lesion came off due to the operation when additional traction was applied.1 case of post-bleeding.The article includes 2 reports as follows: (b)(6): kd-655l or kd-650l and the adverse event.(b)(6): unknown ez clips and the adverse event.This report is 1 of 2 for (b)(6): kd-655l or kd-650l and the adverse event.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Kd-655l or kd-650l; it is unknown which device was used in patient with bleeding.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

The author provided additional information: in the opinion of the author, the post-operative bleeding was not caused by the olympus devices.The author stated, "i recognize that it was a contingency that occurred to some extent after esd, emr, and polypectomy.The author stated the following regarding the tear: after fixing the multi-traction leap stump with the sure clip, when trying to fix the opposite stump of the multi-traction loop to the lesion body side with the ez clip, it was caused by an unreasonable operation of the scope, ez.Not due to clips.The author confirmed no malfunctions occurred during the procedure with the olympus device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: b5, h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 13870215
• MDR Text Key: 293140902
• Report Number: 8010047-2022-04899
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170405624
• UDI-Public: 04953170405624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-655L
• 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: 03/31/2022
• 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: EZ CLIPS, UNKNOW MODEL OR LOT NUMBER.
• Patient Outcome(s): Other