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

Model Number KD-620LR

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Perforation (2001); Pleural Effusion (2010)

Event Date 08/04/2021

Event Type  Injury  

Event Description

It is reported in the literature titled ¿predictors of the difficulty for endoscopic resection of gastric gastrointestinal stromal tumor and follow-up data¿, patients experienced adverse events during/after procedures using olympus devices.Complaint with patient identifier (b)(6) reports kd-611l.Complaint with patient identifier (b)(6) reports kd-620lr.Complaint with patient identifier (b)(6) reports gif-q260j.Complaint with patient identifier (b)(6) reports fd-410lr.Background/aim gastrointestinal stromal tumors (gists) are among the most common submucosal tumors in the stomach that require therapeutic intervention.We aim to identify the predictors of technical difficulty during endoscopic resection of gastric gist and to investigate follow-up outcomes method patients with gastric gists were reviewed from june 2009 to june 2020 at zhongshan hospital.Clinical and pathological features, endoscopic procedure information, and follow-up data were collected and analyzed.A nomogram was developed and validated internally and externally.Results: a total of 628 gists were finally analyzed.The difficulty was experienced in 66 cases.Gists size (2¿3 cm: or 2.431 p = 0.018 and > 3 cm: or 9.765 p < 0.001), invasion depth beyond submucosal (mp: or 2.280, p = 0.038 and mp-ex: or 4.295, p = 0.002), and lack of experience (or 2.075, p = 0.016) were independent risk factors of difficulty.The nomogram prediction model showed a bias-corrected c-index value of 0.778 and acquired an area under curve (auc) of 0.756 on the external validation cohort.At the cut-off of 0.15, the nomogram¿s negative predictive value (npv) and accuracy (acc) were 94.9% and 79.8% in identifying non-difficult gists.Follow-up results showed that only five gist patients had local recurrence after endoscopic resection.Conclusion: tumor size, invasion depth, and endoscopists¿ experience were risk factors for the difficulty of endoscopic gist resection.Our nomogram provided a valuable tool for screening non-difficult gist resection.Difficult procedures were experienced in 66 cases (table 2).Among these cases, 57 patients (86.4%) underwent a procedure of longer than 90 min and clinically significant bleeding happened in 16 cases (24.2%).For postoperative ae, there were 23 cases in total (table 2).Six delayed hemorrhages (26.1%) and four delayed perforations (17.4%) required another endoscopic intervention.Pleural effusion was confirmed in eight cases (34.8%).Postoperative infection with continuous drainage or needed antibiotics treatments happened in 13 patients (56.5%).There is no report of any olympus device malfunction in any procedure described in this study.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: d4, h6, h10.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: 14716124
• MDR Text Key: 295035720
• Report Number: 8010047-2022-10177
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170208409
• UDI-Public: 04953170208409
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-620LR
• 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: 06/27/2022
• 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