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 Hemorrhage/Bleeding (1888); Perforation (2001); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.(b)(4).The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed a literature titled "the value of endoscopic ultrasonography in the endoscopic resection of gastrointestinal stromal tumors." this retrospective, single-center study was aimed to explore the clinical value of endoscopic ultrasonography (eus) in the endoscopic resection of gastrointestinal stromal tumors (gists).A total of 92 patients were included were underwent endoscopic treatment, of which 89 (96.7%) patients underwent complete pathological resection.Of these 92 patients, 37 (40.2%) underwent endoscopic submucosal dissection (esd), 27 (29.4%) underwent endoscopic submucosal excavation (ese), 15 (16.3%) underwent endoscopic full-thickness resection (eftr), nine (9.8%) underwent endoscopic band ligation (ebl), and four (4.3%) underwent submucosal tunneling endoscopic resection (ster).The study reported a 78.7% rate for preoperative diagnosis rate of eus and postoperative pathological diagnosis of gists.The presence of a non-homogeneous echo and liquid anechoic zone in gists often indicated higher risk (p < 0.05).The study concluded that endoscopic resection of gists is feasible and safe.Eus is of great significance for the diagnosis and risk assessment of gists and can assist in the endoscopic resection of gists.Complications: intraoperative bleeding occurred in two patients (2.2%), and both of these cases occurred during ese.Thermal biopsy forceps and titanium clamps were successfully used to stop the bleeding.Perforation occurred in 13 patients (14.1%; cases of perforation during eftr were not included), three of which occurred during ebl, six during esd, and four during ese.These perforations were successfully closed with titanium clips, titanium clips combined with a purse-string suture, or otscs®.After the procedure, electro-coagulation syndrome occurred in seven patients (two cases after esd, two after ese, and three after eftr).All the patients improved after conservative treatments, such as the deprivation of food and water, rehydration, or rational intravenous use of antibiotics.Postoperative perforation occurred in one patient undergoing esd, and the patient improved after surgery.The authors used 4 olympus devices: dual-knife (kd-655l or kd-655q), it-knife (kd-612l), and and hyaline cap ((b)(4)); and reported the following adverse events: adverse events (number of patients): ntraoperative bleeding (2).Intraoperative perforation (13).Postoperative perforation (1).Postoperative coagulation syndrome (7).This article includes 3 reports: (b)(4): kd-612l.(b)(4): kd-655l or kd-655q.(b)(4): d-201-11804.This report is 2 of 3 for (b)(4): kd-655l or kd-655q.Kd-655l was selected as a representative device.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and response from the author.New information added to: b5, d10, h6, h10.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.

Event Description

The author provided additional information: the author stated, in his medical opinion, no adverse events were linked to olympus products in the study.The author also stated the following additional devices were used in the study: gif-q260j, clv-290sl, cv-290.This article includes 4 reports: (b)(6): kd-612l.(b)(6): kd-655l or kd-655q.(b)(6): d-201-11804.(b)(6): gif-q260j.This is 2 of 4: (b)(6): kd-655l or kd-655q.

• 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: 13760336
• MDR Text Key: 292211100
• Report Number: 8010047-2022-04388
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170405624
• UDI-Public: 04953170405624
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/14/2022
• 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: 03/21/2022
• 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: D-201-11804; GIF-Q260J,CLV-290SL,CV-290; KD-612L
• Patient Outcome(s): Other; Required Intervention