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 Gastrointestinal Hemorrhage (4476); Muscle/Tendon Damage (4532)

Event Date 10/05/2020

Event Type  Injury  

Event Description

Olympus received the following literature article: clinical benefit of the multibending endoscope for gastric endoscopic submucosal dissection: a randomized controlled trial by k.Hamada, et al.The study evaluated the safety and efficacy of endoscopic submucosal dissection (esd) using a multibending endoscope in the treatment of superficial gastrointestinal neoplasms.A total of 60 patients were randomized (1:1) to receive conventional esd (c-esd) or multibending esd (m-esd), with no follow-up endoscopy.Patients were permitted to be discharged on the fourth postoperative day and had a postoperative consultation 2 weeks and 6 months after discharge.The evaluation was conducted for esd procedure time, the primary outcome, and the dissection speed, peri-operative complications, intraoperative perforation, delayed bleeding, delayed perforation, and damage to the muscle layers during esd were among the secondary outcomes.The reported median esd procedure time was 36.0 minutes, with a significantly shorter procedure time noticed in the m-esd group.The mean dissection speed was significantly faster in the m-esd group than in the c-esd group.Also, muscle layer damage occurred significantly less frequently in the m-esd group.In conclusion, the study favored m-esd and said a shorter procedure time could decrease not only the risk of complications but also the cost and burden on the medical staff.In the c-esd group, a gif-q260j evis lucera gastrointestinal videoscope with a waterjet system and a kd-655l single use electrosurgical knife/ dualknife j were used.Muscle layer damage was defined as findings in which the circular muscle was damaged by energization of the electrical knife.Complications occurred such as muscle layer damage.In the m-esd group, a gif-2tq260m evis lucera gastrointestinal videoscope and a kd-655l single use electrosurgical knife/ dualknife j were used.Complications occurred such as delayed bleeding and muscle layer damage.The adverse events reported in the study: delayed bleeding (2); muscle layer damage (2).This event includes three (3) reports: (b)(6) for gif-2tq260m: delayed bleeding (2) and muscle layer damage (1); (b)(6) for gif-q260j: muscle layer damage (1); (b)(6) for kd-655l: delayed bleeding (2) and muscle layer damage (2).This is report 3 of 3 for (b)(6) for kd-655l.

Manufacturer Narrative

Average age/years for patients was 73.5 for conventional esd group.Average age/years for patients was 74.2 for multibending esd group.Gender: male (21) and female (9) for conventional esd group.Gender: male (19) and female (11) for multibending esd group.The suspect device has not been returned to olympus for evaluation and the investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Additional information was received from the author.The adverse event was not related to the olympus devices or the underlying condition(s) of the patient.There were no malfunctions of olympus devices in the study.The treatments provided to the patients with adverse events were not provided to olympus.The evis lucera elite video system center, cv-290 was also used in the study.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the author and the results of the legal manufacturer¿s investigation.See updated sections b5, d8, d10, and h10.D10: the cv-290 used in the procedure may have been one or more of the following serial numbers: (b)(6).The legal manufacturer performed an investigation.The dhr review could not be performed as no lot number was reported and there was no device return to inspect for a lot number.If the lot number becomes available at a later date, the dhr shall be reviewed.The root cause of the issue could not be conclusively specified.Based on the reported details, it was likely the event was not caused by a defect in the product, however, the cause of the event could not be identified.

• 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: 13791708
• MDR Text Key: 292985418
• Report Number: 8010047-2022-04541
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-655L
• 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
• Date Manufacturer Received: 03/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: EVIS LUCERA ELITE VIDEO SYSTEM CENTER, CV-290.; GIF-2TQ260M, GASTROINTESTINAL VIDEOSCOPE.; GIF-Q260J, EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE.; VIO 300 D, ELECTROSURGICAL UNIT, ERBE.
• Patient Outcome(s): Other