MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number KD-655L

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

Patient Problems Abdominal Pain (1685); Abscess (1690)

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

On sep.24, 2021, olympus medical systems corp.(omsc) received the literature titled "intraperitoneal abscess as a postoperative complication of gastric endoscopic submucosal dissection".This study was conducted on endoscopic submucosal dissection (esd) for early gastric cancer.The patient was a (b)(6) year-old man undergoing treatment for poorly managed type 2 diabetes mellitus (dm).His glycated hemoglobin (hba1c) level was 10.0%, and he was hypertensive.He had been treated for dm for 10 years and had neuropathy with no evidence of nephropathy.His medications included metformin (2,250 mg/day), voglibose (0.2 mg/day), and vildagliptin (100 mg/day).He had no history of smoking or drinking.In the literature, it was reported that the following.Intraperitoneal abscess (intraperitoneal rupture of the abscess) was found on day 31 after esd as a postoperative complication.He underwent image-guided laparoscopic irrigation.His postoperative course was favorable, and he was discharged after 27 days.Based on the laparoscopic findings, the authors believe that the abscess formation resulted from the esd procedure.The esd procedure was performed using a therapeutic endoscope (gif-q260j) with a transparent attachment cap (d-201-11804).An initial mucosal incision and submucosal dissection were performed using a 2.0-mm dualknife j (kd-655l).Hemostasis for procedural bleeding was attempted using hemostatic forceps (fd-410lr).Based on the available information, reported intraperitoneal abscess (intraperitoneal rupture of the abscess) was not reported in a direct relationship with the olympus products.However, omsc assumes that the intraperitoneal abscess (intraperitoneal rupture of the abscess) might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the intraperitoneal abscess (intraperitoneal rupture of the abscess) might be caused or contributed to a death or serious injury.Therefore, omsc assumes that the intraperitoneal abscess (intraperitoneal rupture of the abscess) was an adverse event to submit.Based on the available information, specific information on the subject device was 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 intraperitoneal abscess (intraperitoneal rupture of the abscess).

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.Lympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 12637207
• MDR Text Key: 277389792
• Report Number: 8010047-2021-13176
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170405624
• UDI-Public: 04953170405624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-655L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male