MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-611L

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

Patient Problems Internal Organ Perforation (1987); Perforation (2001)

Event Date 01/27/2024

Event Type  Injury  

Manufacturer Narrative

The literature described "it knife 2"; therefore, "kd-611l" was selected as representative devices.This report is related to the following linked patient identifiers: (b)(6).The author was not reachable to obtain any further information.The investigation is ongoing, and this report will be supplemented when new and relevant information becomes available later.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "a study of ingenuity of esd for early gastric cancer in s-8 aosagisatsu region".Background and objectives the u region is considered a difficult site for esd in early-stage gastric cancer.The difficulty of esd is particularly high in the nodal region.The reasons for this include easy submersion, thin gastric wall, difficulty in proximity, and lesions facing each other.On the other hand, esd has become possible even in the mandibular region with the use of traction devices and a wide variety of knives and scopes in recent years.We will review the results of esd in our clinic and explore effective esd techniques.Methods we retrospectively reviewed the results of esd and details of the technique in (b)(4) cases of early gastric cancer located in the nuchal region out of (b)(4) cases and (b)(4) lesions of early gastric cancer esd performed at our hospital from (b)(6) 2004 to (b)(6) 2023.The gif-q260j and gif-h290t scopes were defined as standard scopes, and the other scopes were defined as special scopes.Results: median age 66 years, gender (male/female) 16/8, gross type: 0-ila 8 cases, 0-ilb 8 cases, 0-ilc 8 cases, h.Pylori: negative 15 cases, positive 9 cases, site: anterior wall 1 case, posterior wall 5 cases, large crossbow 10 cases, apical 8 cases, postoperative reconstructed stomach 2 cases.Median resection lesion diameter was 14 mm, median resection specimen diameter was 36 mm, depth (m/sm1/sm2) was 14/5/5, ul was 1 case, and positive vascular invasion was 1 case.The median treatment time was 141 minutes, and all patients underwent complete en bloc resection.No posterior hemorrhage or delayed perforation was observed.Intraoperative perforation was observed in 4 patients (17%), but it could be treated conservatively.Details of the procedure: all patients received co2 insufflation, 3 high-frequency knives (flash knife bt 1.5mm or 2.Omm, it knife 2, and clutch cutter), traction method in 6 cases without and 18 cases with, special scope in 7 cases (b)(6) and (b)(6).In the perforation cases, none of the 4 cases used the special scope, and 3 cases were located at the apex, and the technique was performed in the field of view with the knife facing the muscle layer.Perforation in cases using the special scope was (b)(6), whereas perforation with the normal scope was (b)(6) (p=(b)(6)).The use of the special scope was considered to be a factor in avoiding perforation because it provided a field of view parallel to the muscle layer.Conclusion although the rate of esd perforation in the nodal region is as high as (b)(6) and the choice of treatment method requires more careful consideration, the use of a special scope may reduce the risk of esd perforation.Type of adverse events/number of patients.Intraoperative perforation (n=(b)(6)).

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 serial and/or 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, a 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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18889724
• MDR Text Key: 337511856
• Report Number: 9614641-2024-00644
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• 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,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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-611L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/21/2024
• 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: GIF-H290T; GIF-Q260J
• Patient Outcome(s): Other