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

Model Number SD-210U-15

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Fever (1858); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic mucosal resection of gastrointestinal polyps with a novel low-temperature plasma radio frequency generator: a non-inferiority multi-center randomized control study."     ¿literature summary¿ abstract background to evaluate the efficacy and safety of novel plasma radio frequency generator and its single-use polypectomy snares for endoscopic mucosal resection (emr) of gastrointestinal (gi) polyps.Methods a total of 217 patients with 413 gi polyps were recruited from four centers in china.Patients were assigned to experimental or control groups using a central randomization method.The experimental group used the novel plasma radio frequency generator and its matched single-use polypectomy snares (neowing, shanghai), while the control group used the high-frequency electrosurgical unit (erbe, germany) and disposable electrosurgical snares (olympus, japan).The primary endpoint was the en bloc resection rate, and the non-inferiority margin was set at 10%.Secondary endpoint included operation 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).The operation time was 29.14 ± 20.21 min in the experimental group and 30.26 ± 18.74 min in the control group (p = 0.671).The average removal time of a single polyp in the experimental group was 7.52 ± 4.45 min, which was slightly shorter than that in the control group 8.90 ± 6.67 min, with no statistical difference (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).No intraoperative perforation occurred in either group.The postoperative bleeding rates of the experimental group and the control group were 1.87% (2/107) and 4.55% (5/110), respectively (p = 0.465).No postoperative perforation occurred in the experimental group (0/107), while one case of delayed perforation occurred in the control group (1/110, 0.91%).There was no statistical difference between the two groups.Conclusions endoscopic mucosal resection of gi polyps with the novel plasma radio frequency generator is safe and effective, and non-inferior to the conventional high-frequency electrosurgical system.    ¿type of adverse events/number of patients¿ event1: intraoperative bleeding (experimental group) 9 cases event2: intraoperative bleeding (control group) 11 cases event3: postoperative bleeding (experimental group) 2 cases event4: postoperative bleeding (control group) 5 cases event5: postoperative perforation (control group) 1 case event6: chest pain or abdominal pain (experimental group) 3 cases event7: chest pain or abdominal pain (control group) 3 cases event8: postoperative fever (experimental group) 1 case event9: readmission or prolonged hospitalization (control group) 4 cases  .

Manufacturer Narrative

The literature described electrosurgical snares olympus, japan, sd-210u-10, sd-210u-15, sd-210u-25 used in the literature.Olympus selected sd-210u-15 as the representative model.The reported is related to the following linked patient identifiers.(b)(6).Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

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 events 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: 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 (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: 18774977
• MDR Text Key: 336210027
• Report Number: 9614641-2024-00467
• Device Sequence Number: 1
• Product Code: FDI
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD-210U-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• 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: COLONOVIDEOSCOPE, CF-H290I , SN-UNK; EVIS LUCERA COLONOVIDEOSCOPE, CF-H260AI, SN UNK; IMAGING SYSTEM, CV-290, SN -UNK
• Patient Outcome(s): Required Intervention; Hospitalization