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

Model Number KD-611L

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

Patient Problem Bowel Perforation (2668)

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 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 Description

Olympus medical systems corp. (omsc) received a literature titled "hybrid endoscopic submucosal dissection: an alternative resection modality for large laterally spreading tumors in the cecum?". The literature reported the result of 62 patients with large laterally spreading tumors in the cecum who underwent hybrid endoscopic submucosal dissection (esd) procedure using olympus dual or it knife and non olympus polypectomy snare between january of 2008 and june of 2019. In the literature, it was reported complication as follows; (1) post-procedure bleeding (1case): it was described in the literature as follows. " one patient with post-procedure bleeding was successfully treated with endoscopic hemostasis therapy. " (2) perforation (1case): it was described in the literature as follows. " one patient perforated during the esd procedure, which was surgically treated. " (3) post-procedure abdominal pain and fever (11 cases) (4) additional surgery (3cases): it was described in the clinical outcomes of the literature as follows. "two patients in the esd group and one patient in the hybrid esd group underwent additional surgery. " (5) recurrence (1case). 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, omsc assumes that "perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury. Omsc also assumed that "additional surgery" was not related to the subject device because it was not described under "complication" in the literature, but as a "clinical outcome". Therefore, omsc determined that the "perforation" was adverse event to submit. Omsc will submit a medical device report (mdr) depending on the event.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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: 12538201
• MDR Text Key: 273623573
• Report Number: 8010047-2021-12357
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-611L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: Initial

Patient Treatment Data

Date Received: 09/27/2021 Patient Sequence Number: 1