MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650L

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

Patient Problem Internal Organ Perforation (1987)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.Since the literature described "dualknife", we selected "kd-650l" as a representative product.The exact model number is not known.

Event Description

It is reported in the literature titled "p-270 outcome of esophageal and gastric esd under general anesthesia at our hospital", two patients experienced microperforations requiring endoscopic clipping.Objective: although the technique and safety of esophageal and gastric endoscopic submucosal dissection (esd) are well established, we have experienced cases in which patients are not adequately sedated by intravenous anesthesia due to patient background or prolonged treatment time, resulting in oversedation, disinhibition, treatment interruption, accidental injury, and divided resection.We have introduced esd under general anesthesia for such patients with esophageal and gastric tumors and investigated the results of treatment.Subjects: fifteen patients with esophageal and gastric tumors who underwent esd under general anesthesia between march 2021 and march 2022 (including one patient with overlapping esophageal and gastric lesions), 21 lesions.Results: the mean age was 69.8±14.9 years.Comorbidities were renal disorder in 1 case, ventilatory impairment in 4 cases, diabetes mellitus in 2 cases, and multi-organ cancer in 2 cases.6 patients had 8 lesions (ut:3, mt:4, ae:1 lesion) in esophagus and 10 patients had 13 lesions (u:4, m:2, l:7 lesions) in stomach.The median lesion length was 25.6 (12-30) mm, and the median short diameter was 20.2 (8-23) mm.Dualknife was used in all patients, and the median resection time was 91.5 (42.5-112.5) minutes.General anesthesia was selected because of 1 case of poor sedation by intravenous anesthesia, 3 cases of multiple lesions, 9 cases of high technical difficulty (4 cases of leprosy/epigastric cancer, 1 case of esophageal cancer after jejunal reconstruction, 1 case of duodenal invasive gastric cancer, 1 case of palette adenocarcinoma, 2 giant lesions), 1 case of submucosal tumor of esophagus, 1 case of gastric cancer overlapping esophageal cancer, all patients were treated successfully.Two patients had intraoperative microperforations, which were sutured with clips after resection of the lesions and treated conservatively.Two esophageal lesions were not cured, and one patient underwent additional surgical resection, while the other patient preferred to be followed up.The endoscopic cure rate of gastric lesions was ecuraa: 6, ecurab: 1, and ecurac-2: 3.The mean postoperative hospital stay was 62 (±1.3) days, and there were no deviations from the clinical path except for 2 cases with intraoperative perforation.Conclusion: esd under general anesthesia was useful in that it was completed without interruption in all cases of esophageal and gastric esd, where prolonged treatment and sedation by intravenous anesthesia were expected to be difficult.

Manufacturer Narrative

This report is being updated to report additional information provided by the authoring physician.New information is reported in b5.

Event Description

Update: additional information provided: the authoring physician stated that no olympus device caused or contributed to the adverse events experienced by patients in this study.

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, the 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 KD-650
• 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: 15843980
• MDR Text Key: 304107971
• Report Number: 9614641-2022-00653
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2022

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-650L
• 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: 10/27/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 12/23/2022
• Supplement Dates FDA Received: 12/08/2022; 12/27/2022
• 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): Required Intervention; Other