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

Model Number	KD-630L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
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 february 8, 2021, olympus medical systems corp.(omsc) received the literature titled "safety and efficacy of endoscopic submucosal dissection for non-ampullary duodenal neoplasms: a case series".This study was conducted on the endoscopic submucosal dissection (esd) for 16 patients with non-ampullary duodenal neoplasms between february 2011 to november 2014.In the literature, it was reported that one perforation occurred during submucosal dissection using the subject device (kd-630l), and urgent surgery was performed after additional snare emr.After the urgent surgery, the patient needed a longer hospital stay (36 days) due to postoperative partial small bowel obstruction.Based on the available information, specific information on the subject device and the perforation patients were not provided.There is no description of the device's malfunction.Omsc will submit one medical device reports (mdr) of the subject device for perforation.

• 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
• MDR Report Key: 11356162
• Report Number: 8010047-2021-02850
• Device Sequence Number: 3439848
• Product Code: KNS
• UDI-Device Identifier: 04953170208416
• UDI-Public: 04953170208416
• 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: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2021

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: No Information
• Device Model Number: KD-630L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/20/2021
• 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: Hospitalization; Required Intervention