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 Hemorrhage/Bleeding (1888)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature titled: ¿efficacy and safety of hybrid endoscopic submucosal dissection compared with endoscopic submucosal dissection for rectal neuroendocrine tumors and risk factors associated with incomplete endoscopic resection,¿ patients experienced adverse events after endoscopic submucosal dissection (esd) procedures using olympus devices.Case with patient identifier (b)(6) reports it knife.Case with patient identifier (b)(6) reports dual knife.Case with patient identifier (b)(6) reports single channel endoscope (pcf-260j).Study background/aim: neuroendocrine tumors (nets) are rising in prevalence, particularly with the rectal area.This study evaluated and compared the safety and effectiveness of hybrid endoscopic submucosal dissection (esd) with those of esd for rectal nets and risk factors associated with incomplete endoscopic resection.Method: a total of 272 consecutive patients who underwent esd or hybrid esd for rectal nets at the (b)(6) hospital in the period from february 2011 to september 2018 were involved in this study.Data were collected from clinical and endoscopic databases.The procedure time, en bloc resection, complete resection, complication, and recurrence rates were evaluated.Results: in the hybrid esd group were 111 patients (who had 119 lesions between them), with a further 161 patients (164 lesions) in the esd group.No significance was found in baseline characteristics between the two groups.Hybrid esd had a significantly shorter mean procedure time than esd (13.2±8.3 vs.18.1±9.7 min, p=0.000).Hybrid esd showed similar en bloc resection (99.2% vs.98.2%; p=0.373), complete resection (94.1% vs.90.9%, p=0.641), and postprocedural bleeding (2.5% vs.0.6%, p=0.313) rates to esd.Univariate and multivariate analysis showed that higher histopathological grade was associated with incomplete resection.Conclusion: for rectal net, both esd and hybrid esd are effective and safe forms of treatment.Hybrid esd provides an alternative option in the treatment of rectal nets.Further developments are needed to improve the complete resection rate, especially concerning tumors with higher histopathological grade.Three patients who underwent hybrid esd experienced postprocedural bleeding, as did one in the esd group, and these patients received endoscopic hemostasis treatment successfully.Perforation did not occur in either group.One patient in the esd group experienced recurrence, which was confirmed by biopsy during the follow-up endoscopic examination 1 year after the esd procedure.During the follow-up period, no evidence of recurrence or metastasis was detected in the other patients in either of the groups.Two patients who underwent esd, and one patient who underwent hybrid esd received additional surgery.The postoperative pathology results showed no positive tumor cells in two of the patients.Tumor cells were detected on the base of the ulcer in the other patient but without lymph nodes metastasis.There is no report of olympus device malfunction described 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 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.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): 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: 14164613
• MDR Text Key: 293925272
• Report Number: 8010047-2022-06744
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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
• Date Manufacturer Received: 06/20/2022
• 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