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

Model Number	KD-655Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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 sep.21, 2021, olympus medical systems corp.(omsc) received the literature titled "clinical utility of the pocket-creation method with a traction device for colorectal endoscopic submucosal dissection".In this study, 324 colorectal lesions treated with endoscopic submucosal dissection (esd) from july 2018 to june 2019 were included.The following three treatment strategies were used: conventional esd (ce), ce with traction device(td), and pocket-creation method(pcm) with td.In the literature, it was reported that the following.*immediate perforation, delayed perforation, postoperative bleeding occurred in 6, 1, and 11 cases, respectively.*delayed perforation occurred in one case in the ce group and emergency surgery was performed on the day following esd.The condition was not life-threatening.*immediate perforations in six cases were treated conservatively.*postoperative bleeding was defined as hematochezia occurring within 2 weeks after esd that required endoscopic hemostasis.*all the esd procedures were performed using a single-channel endoscope with the water-jet system (gif-q260j for lesions in the rectum or the distal colon and pcf-q260j for lesions in the proximal colon), with a large opening end attachment (d-201-11804).*dual knife j (kd-655q) was used for the mucosal incision and submucosal dissection.Based on the available information, reported immediate perforation, delayed perforation, postoperative bleeding were not reported in a direct relationship with the olympus products.However, omsc assumes that the delayed perforation 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 immediate perforations and the postoperative bleeding were not serious due to the following report: *immediate perforations in six cases were treated conservatively.*postoperative bleeding was defined as hematochezia occurring within 2 weeks after esd that required endoscopic hemostasis.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 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.Correction to g2, h8.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: 12566765
• Report Number: 8010047-2021-12631
• Device Sequence Number: 19107618
• Product Code: KNS
• UDI-Device Identifier: 04953170377518
• UDI-Public: 04953170377518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2022

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-655Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 04/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown