MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210U-25

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 05/01/2022

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.

Event Description

It is reported in the literature titled "endoscopic mucosal resection of gastrointestinal polyps with a novel plasma radiofrequency generator--a non-inferiority multicenter randomized control study'" patient's experienced adverse effects during/after procedures.Aim: to evaluate the efficacy and safety of novel plasma radiofrequency generator for endoscopic mucosal resection (emr) of gastrointestinal polyps.Methods: from october 2019 to may 2021, 217 cases of gastrointestinal polyps were included from 4 centers in china.Among them, 206 cases were colorectal polyps and 12 cases were gastric polyps (1 case had both).All the cases were randomly assigned to either the experimental group (107 cases) or the control group (110 cases).The experimental group used the novel plasma radiofrequency generator and its matched disposable electric snares, while the control group used the high-frequency electrosurgical system (erbe, germany) and disposable electric snares (olympus, japan).The primary outcome was the en bloc resection rate.Secondary outcomes included operative time, coagulation success rate, intraoperative and postoperative bleeding rate, and perforation rate.Results: the en bloc resection rate was 97.20% (104/107) in the experimental group and 95.45% (105/110) in the control group (p = 0.496) (fig.1).Operation time was (29.14 - 20.21) min in the experimental group and (30.26 18.74) min in the control group.The average removal time of a single polyp in the experimental group was (7.52 - 4.45) min, slightly shorter than that in the control group (8.90 6.67) min (p = 0.076).The intraoperative bleeding rates of the experimental group and control group were 8.41% (9/107) and 10.00% (11/110), respectively (p = 0.686).The coagulation success rate in the experimental group and control group was 11.11% (1/9) and 9.09% (1/11) (p = 0.881), respectively.No intraoperative perforation occurred in both groups.The postoperative bleeding rate of the experimental group was 1.87% (2/107), lower than that of the control group 4.55% (5/110) (p = 0.265).There was no postoperative perforation in the experimental group (0/107), while there was one case of delayed perforation in the control group.Conclusions: emr of gastrointestinal polyps with the novel plasma radiofrequency generator is safe and effective.There is no report of any olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

This supplemental report is being submitted to provide corrections and additional information from the author.New information was added to the following fields: b5.Correction: b3, d4.

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events.The author stated there was no malfunction of the olympus device.

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.Correction: this supplemental report includes a correction to b3.Date corrected to 01may2022.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15312810
• MDR Text Key: 298855326
• Report Number: 9614641-2022-00226
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170298431
• UDI-Public: 04953170298431
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K902735
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-25
• 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: 09/22/2022
• 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