MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650L

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

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

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the lot number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there was no description of the device's malfunction.

Event Description

On october 4, olympus medical systems corp. (omsc) received the literature "impact of obesity in colorectal endoscopic submucosal dissection: single-center retrospective cohort study¿. The purpose of the literature was to evaluate the clinical impact of obesity in patients who underwent colorectal endoscopic submucosal dissection (esd). The esd was performed using a knife (kd-630l or kd-650l), an endoscope (pcf-q260 ji or gif-q260j), and a transparent attachment (d-201-11802). A high-frequency generator was also used but was manufactured by non-olympus. Delayed bleeding after esd was defined as a decrease in the hemoglobin level by at least 2 g/dl or more below the most recent preoperative level, and/ or the necessitation of blood transfusion and/or marked hematochezia. A delayed event after colorectal esd was defined as an adverse event other than bleeding and perforation if it occurred within 30 days after esd was performed. In the literature, it was reported 13 delayed bleedings, 7 perforations, 8 post-esd coagulation syndromes, 3 pulmonary embolisms, 2 sick sinus syndromes, 1 subarachnoid hemorrhage, and 10 deaths. All the patients with delayed bleeding were treated with endoscopic hemostasis. The literature wrote as below: ¿three of the perforation were treated with endoscopic closure, and one underwent emergency surgery for delayed perforation. ¿ and ¿during the follow-up period (range, 2¿87 months), none of the patients died as a result of colorectal cancer, although 10 patients died as a result of other diseases (5 from lung cancer, 1 from malignant lymphoma, and 4 from unknown causes). ¿ the other 4 perforations and post-esd coagulation syndrome were no information in the literature. Medical safety officers, who have doctor license in olympus, said that delayed bleeding and delayed perforation are serious injury, which are related to esd procedures, and cannot be denied to be related to the equipment (knife) used for mucosal dissection and resection in esd. Also, in the case of death, the cause of death is described in the literature, and it is judged to be unrelated with olympus devices. In addition, it is reasonable to conclude that pulmonary embolism, sick sinus syndrome, and subarachnoid hemorrhage, for which detailed information is not provided, have little relevance. According to the harm list ver. 18, the severalty of three perforations completed with endoscopic closure is the level 3 (id: 07-27-026), but the severalty of one delayed perforation required emergency surgery is the level 4 (id: 07-27-073), which is severe. Based on the available information, a direct relationship between the olympus product and these complications could not be determined. However, 13 cases of delayed bleeding that may have necessitated a blood transfusion, one delayed perforation required an emergency surgery, and 4 perforations which the details of was unknown might be serious injuries, and the olympus knife might be associated with these injuries. This is the report regarding 13 cases of delayed bleeding that may have necessitated a blood transfusion, one delayed perforation required an emergency surgery, and 4 perforations which the details of was unknown.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• 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: 12637988
• MDR Text Key: 277148869
• Report Number: 8010047-2021-13190
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: KD-650L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2022
• 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: Unkown

Patient Treatment Data

Date Received: 10/15/2021 Patient Sequence Number: 1