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

Model Number KD-620LR

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "usefulness of serum opsonic activity measured by chemiluminescence method to assess the invasiveness of colorectal endoscopic mucosal dissection".Literature summary: the aim of this study was to evaluate the physical stress due to colorectal endoscopic submucosal dissection based on changes in serum opsonic activity (soa).Soa was examined by measuring reactive oxygen species (ros) produced by neutrophils using lucigenin-dependent chemiluminescence (lgcl) and luminoldependent chemiluminescence (lmcl).Sixty-nine patients were enrolled into the study and examined soa in the morning of the day of esd, the next day, and at 4 days after esd.The peak height (ph) and area under the curve (auc) of lgcl showed no significant difference between the day and the next day, whereas the ph and auc for lgcl were significantly higher 4 days after esd than on the day of esd (p<0.05).In contrast, the ph and auc of lmcl showed no significant changes during the esd perioperative period.This difference suggests that soa changes during the colorectal esd perioperative period involved minor increases in the production of lower-toxicity ros.This finding supported the position that esd is a technique that does not generate a great deal of physical stress.On the other hand, a significant increase in soa at 4 days after colorectal esd suggests that care is needed with postoperative management even after the patient has started to eat meals again.Esd was performed using a conventional single channel endoscope (pcf-q260ji or gif-q260j; olympus, tokyo, japan) with hood.Pcf-q260ji was selected as a representative product.Type of adverse events/number of patients.Hemorrhage - (5).Perforation - (1).Fever at 37.5ºc or higher - (2).Recovery from all of these was achieved by internal medical treatment.This article includes 2 reports: patient identifier (b)(6)-pcf-q260ji.Patient identifier (b)(6).This is report 2 of 2 for patient identifier (b)(6)-kd-620lr.

Manufacturer Narrative

This supplemental report is being submitted to provide the author's additional information and the legal manufacturer's investigation.B1: no change in reportability.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

Additional information received from the author: in the opinion of the author, the adverse events were not caused or contributed by the olympus devices.The author reported the bleeding was treated with hemostasis and the other complications were the extension of the fasting period.

• 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: 14400177
• MDR Text Key: 294599872
• Report Number: 8010047-2022-08236
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/13/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/17/2022
• 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
• Treatment: PCF-Q260JI OR GIF-Q260J, SERIAL UNKNOWN.
• Patient Outcome(s): Other