MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE ELECTROSURGICAL SNARE

Model Number SD-210U-25

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature article: "efficacy and safety of cold versus hot snare polypectomy for small (5-9 mm) colorectal polyps: a multicenter randomized controlled trial."     literature summary: this study compared cold snare polypectomy (csp) and hot snare polypectomy (hsp) in 5¿9mm polyps in terms of complete resection and adverse events.496 patients were randomized: 237 (394 polyps) to csp and 259 (397 polyps) to hsp.Complete polypectomy rates were 92.5% with csp and 94.0% with hsp (difference 1.5%, 95% confidence interval ¿1.9% to 4.9%).Intraprocedural bleeding occurred during three csps (0.8 %) and seven hsps (1.8%) (p = 0.34).One lesion per group (0.4 %) presented delayed hemorrhage.Post colonoscopy abdominal pain presented similarly in both groups 1 hour after the procedure (csp 18.8% vs.Hsp 18.4%) but was higher in the hsp group after 5 hours (5.9% vs.16.5%; p = 0.02).A higher proportion of patients were asymptomatic 24 hours after csp than after hsp (97% vs.86.4%; p=0.01).This showed no differences in complete resection and bleeding rates between csp and hsp.Csp reduced the intensity and duration of post-colonoscopy abdominal pain.    type of adverse events/number of patients: csp, intraprocedural bleeding - (3), delayed hemorrhage - (2).Hsp: intraprocedural bleeding - (7).Intraprocedural bleeding was defined as spurting or oozing that continued after 60 seconds of observation without continuous washing.Bleeding that ceased within the 60-second observation time was not labelled as an adverse event but was instead recorded as a self-limited bleed.Delayed hemorrhage was defined as rectal bleeding between discharge and the telephone follow-up contact.Since the literature described "25mm round snare", we selected "sd-210u-25" as a representative product.

Event Description

Additional information received from the author: in the opinion of the author, there were no notable situations other than possible bleeding after polypectomy in larger lesions, which is a common occurrence.The author also stated the model of loop used was not recorded as it was not the object of the study, only whether it was a cold or hot loop.

Manufacturer Narrative

B1: additional information from the author does not change reportability of the adverse events.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: DISPOSABLE ELECTROSURGICAL SNARE
• Type of Device: DISPOSABLE ELECTROSURGICAL SNARE
• 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: 14251347
• MDR Text Key: 294171306
• Report Number: 8010047-2022-07329
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170298431
• UDI-Public: 04953170298431
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K902735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• 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: 05/18/2022
• 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