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

Model Number	KD-650Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
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
On (b)(6) 2021, olympus medical systems corp.(omsc) received the literature titled "endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum".In this study, 47 colorectal lesions treated with endoscopic submucosal dissection (esd) between january 2014 and april 2019 were included.The 47 subjects consisted of 27 male and 20 female patients with a mean age of (b)(6).In the literature, it was reported that the following."delayed perforation, delayed bleeding, fever, and abdominal pain occurred in 1, 1, 4, and 5 patients, respectively."two days after the esd, a strong tenderness was observed in the right lower abdomen, and ct revealed free air around the treatment area.The patient was diagnosed as having developed post operative delayed perforation, and emergency surgery was performed.Based on the available information, reported delayed perforation, delayed bleeding, fever, abdominal pain were not reported in a direct relationship with the olympus products.However, omsc assumes that the delayed perforation and the delayed bleeding might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the delayed perforation might be caused or contributed to a death or serious injury.Omsc assumes that the delayed bleeding, the fever and the abdominal pain were not serious due to the following report: *delayed bleeding was successfully controlled by endoscopic hemostasis.*four patients developed high-grade fever (38°c) and five patients developed transient severe abdominal pain; however, all of these patients improved conservatively with antibiotics.Therefore, omsc assumes that the delayed perforation was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the delayed perforation.
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
On nov.8, 2021, olympus medical systems corp.(omsc) received the literature titled "endoscopic submucosal dissection for colorectal neoplasms in proximity or extending to a diverticulum".In this study, 47 colorectal lesions treated with endoscopic submucosal dissection (esd) between january 2014 and april 2019 were included.The 47 subjects consisted of 27 male and 20 female patients with a mean age of 72.9 ± 9.8 years.In the literature, it was reported that the following.*delayed perforation, delayed bleeding, fever, and abdominal pain occurred in 1, 1, 4, and 5 patients, respectively.*two days after the esd, a strong tenderness was observed in the right lower abdomen, and ct revealed free air around the treatment area.The patient was diagnosed as having developed post operative delayed perforation, and emergency surgery was performed.Based on the available information, reported delayed perforation, delayed bleeding, fever, abdominal pain were not reported in a direct relationship with the olympus products.However, omsc assumes that the delayed perforation and the delayed bleeding might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the delayed perforation might be caused or contributed to a death or serious injury.Omsc assumes that the delayed bleeding, the fever and the abdominal pain were not serious due to the following report: *delayed bleeding was successfully controlled by endoscopic hemostasis.*four patients developed high-grade fever (>38°c) and five patients developed transient severe abdominal pain; however, all of these patients improved conservatively with antibiotics.Therefore, omsc assumes that the delayed perforation was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the delayed perforation.
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
• 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: 12921878
• Report Number: 8010047-2021-15457
• Device Sequence Number: 5143075
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 12/02/2021
• Supplement Report FDA Received Date: 04/19/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown