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

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "factors predicting technical difficulties during endoscopic submucosal excavation for gastric submucosal tumor".The literature reported the result of gastric submucosal tumors patients who underwent endoscopic submucosal excavation (ese) procedure using olympus (b)(4) and another device from april 2011 to december 2019.In the literature, it was reported complication as follows; (delayed bleeding (2 cases).(fever (2 cases).(chest pain (1 case).(massive intraoperative bleeding (1 case).There are not mentioned that these complications were related to the subject device in question.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, there is a statement in the literature as follows one patient with "delayed bleeding" underwent additional endoscopic treatment.One patient underwent laparoscopic surgery because of "massive intraoperative bleeding." omsc assumes that "massive intraoperative bleeding" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.In addition, during the medical safety officer (mso) review within the omsc, the review was determined that "delayed bleeding underwent additional endoscopic treatment" may be related to the subject device and that the subject device may have caused death or serious injury.Therefore, omsc assumes that "delayed bleeding underwent additional endoscopic treatment" and "massive intraoperative bleeding" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Omsc determined that the events were adverse event to submit.Omsc will submit two medical device reports (mdrs) depending on the events.This report is a "massive intraoperative bleeding".
Additional 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 serial 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 is no description of the device's malfunction.
Additional 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 serial 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 is no description of the device's malfunction.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "factors predicting technical difficulties during endoscopic submucosal excavation for gastric submucosal tumor".The literature reported the result of gastric submucosal tumors patients who underwent endoscopic submucosal excavation (ese) procedure using olympus kd-650q and another device from april 2011 to december 2019.In the literature, it was reported complication as follows; (delayed bleeding (2 cases).(fever (2 cases).(chest pain (1 case).(massive intraoperative bleeding (1 case).There are not mentioned that these complications were related to the subject device in question.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, there is a statement in the literature as follows one patient with "delayed bleeding" underwent additional endoscopic treatment.One patient underwent laparoscopic surgery because of "massive intraoperative bleeding." omsc assumes that "massive intraoperative bleeding" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.In addition, during the medical safety officer (mso) review within the omsc, the review was determined that "delayed bleeding underwent additional endoscopic treatment" may be related to the subject device and that the subject device may have caused death or serious injury.Therefore, omsc assumes that "delayed bleeding underwent additional endoscopic treatment" and "massive intraoperative bleeding" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Omsc determined that the events were adverse event to submit.Omsc will submit two medical device reports (mdrs) depending on the events.This report is a "massive intraoperative bleeding".
Additional 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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Common Device Name: 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: 12913899
• Report Number: 8010047-2021-15369
• Device Sequence Number: 3961665
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KD-650Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown