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

Model Number KD-610L

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

Patient Problem Stenosis of the esophagus (4487)

Event Type  Injury  

Event Description

Olympus reviewed the following literature: "effect of different devices on esophageal esd on esophageal stricture"     literature summary.[background / purpose] extensive resection is the main cause of stenosis in esophageal esd, and administration of steroids is useful for its prevention.However, the current situation is that postoperative stenosis cannot be completely prevented even if stenosis prevention measures are taken.When we examined esd procedures that did not cause stenosis, we suspected that there might be differences in the stenosis rate depending on the device.This time, we will clarify the effect of different devices on post-esophageal esd stenosis using a systematic review (study 1: sl), and pathologically evaluate the difference in cases with additional resection after esophageal esd (studv2): s2).[method] search for articles up to 2020 using s1: pubmed, cochrane library, and ichushi.The criteria for adoption are esd for squamous cell carcinoma of the esophagus and preesophageal carcinoma lesions, peri-material 3/4 or more laps, and stenosis.Exclusion criteria were ce and ae, which are prone to stenosis, stenosis preventive treatment, and preoperative and postoperative treatment.Eight papers were finally evaluated from the collected 928 papers.S2: among the 17 years of additional resection after esophageal esd in 2004-2021, cases without stenosis prevention measures were selected.It was predicted that (1) muscular layer atrophy, (2) collagen fiber thickening, and (3) disappearance of blood vessels in the submucosal layer would be observed due to esophageal stricture.[results] the devices used in s1: 8 were it knife (hereinafter knife omitted), hook, flush, and dual.The stenosis rate is it / hook / dua1 = 10/12 (83%), 16/39 (41), 10/15 (67) for each device of mucosal incision (hereinafter referred to as incision).It / hook / flush / dual = 15/23 (65%) / 11/28 (39) / 19/29 (66) / 10/15 (67) for each device of submucosal dissection (hereinafter dissection).Comparing all devices in 2 groups, only hook vs non-hook, stenosis rate is incision / dissection: n = 39 vs n = 60 / n = 28 vs n = 100: 41 vs 70/39 vs 66: p = 0.0064 / p = 0.0157 was significantly lower.Based on s2: s1, the comparison was narrowed down to 1 case of hook and 3 cases of it.The hook case had no muscular atrophy, the collagen fibers were thin, and the submucosal blood vessels were preserved in 5 places.In all it cases, muscular atrophy was present, collagen fibers were thickened in 2 cases, and submucosal blood vessels remained in only 1-2 sites.[discussion] in s1: hook, by hooking the tissue and making an incision, it was possible to remove the incision while avoiding energization to the deep part, and it was speculated that the stenosis rate decreased.S2; although it is a small number of studies, it is considered that the submucosal exfoliation could be performed without reaching the deep part in that hook does not have muscular atrophy and the blood vessels in the submucosal layer are preserved.[conclusion] so far, there is no report that directly compares the difference in stenosis rate between devices.Indirect comparison using a systematic review and pathological evaluation at our institution suggested that hook may reduce the stenosis rate.Type of adverse events/number of patients.Stenosis after esophageal esd (4).  we selected "kd-610l" as a representative product of itknife.Since the literature described "hookknife", we selected "kd-625lr" as a representative product for hookknife.Study1 is excluded because it is an analysis of other papers.We evaluate study 2 that the authors experienced.In study2, pathological evaluation was performed on 1 hook case and 3 it cases among the additional resection cases for post-esophageal esd stenosis for 17 years from 2004 to 2021.This article includes 2 reports: (b)(6): kd-610l.(b)(6): kd-625lr.This report is 1 of 2 for (b)(6): kd-610l.

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.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr and provide additional information.New information added to b5 and h10.After receiving additional information from the author, the adverse events reported in the literature article have been determined not to be serious injuries.

Event Description

Additional information received from the author: the author stated the olympus device did not cause or contribute to the adverse event.The author stated the patients organ development and pulsation may have contributed to the adverse event.The author stated the treatment for the adverse event was bougie steroid local injection and follow up every two weeks.The author confirmed no malfunctions of olympus devices occurred.

• 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: 14657315
• MDR Text Key: 294868074
• Report Number: 8010047-2022-09856
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• 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: 07/14/2022

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-610L
• 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: 05/11/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/14/2022
• 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): Other