MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DISTAL HOOD

Model Number	MAJ-1990
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled ¿low-power pure-cut hot snare polypectomy for colorectal polyps 10-14 mm in size: a multicenter retrospective study¿.Background and aim: hot snare excision using electrocautery is widely used for large colorectal polyps (>10 mm); however, adverse events occur due to deep thermal injury.Colorectal polyps measuring 10¿14 mm rarely include invasive cancer.Therefore, less invasive therapeutic options for this size category are demanding.We have developed hot snare polypectomy with low-power pure-cut current (lppc hsp), which is expected to contribute to less deep thermal damage and lower risk of adverse events.This study aimed to evaluate the efficacy and safety of lppc hsp for 10¿14 mm colorectal polyps, compared with conventional endoscopic mucosal resection (emr).Methods: in this multicenter, retrospective, observational study, clinical outcomes of emr and lppc hsp for 10¿14 mm nonpedunculated colorectal polyps between (b)(6) 2021 and (b)(6) 2022 were compared using propensity score matching.Results: we identified (b)(4).After propensity score matching, the baseline characteristics between the groups were comparable, with (b)(4) pairs.The en bloc and r0 resection rates were not significantly different between emr and lppc hsp groups (95.8% vs 97.5%, p = 0.72; 90.0% vs 91.7%, p = 0.82).Immediate bleeding, delayed bleeding, and perforation rate did not differ between the two groups (5/8% vs 2.5%, p = 0.33, 0% vs 0.8% p = 1.00, 0% vs 0%).Conclusions: compared with conventional emr, lppc hsp showed a similar resection ability without an increase in adverse events.These results suggest that lppc hsp is a safe and effective treatment for 10¿14 mm nonpedunculated colorectal polyps.Type of adverse events/number of patients: - immediate bleeding ((b)(4)).- delayed bleeding: ((b)(4)).
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.This report is related to the following patient identifiers: (b)(6).
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.The device has not been returned to olympus for evaluation.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.The device has not been returned to olympus for evaluation.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL HOOD
• Common Device Name: DISTAL HOOD
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20775853
• Report Number: 9610595-2024-40206
• Device Sequence Number: 4388105
• Product Code: FDS
• UDI-Device Identifier: 04953170314407
• UDI-Public: 04953170314407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAJ-1990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COLONOSCOPE CF-EZ1500DI; COLONOSCOPE CF-HQ290ZI; COLONOSCOPE CF-XZ1200I; COLONOSCOPE EC-L600Z (FUJIFILM); DISTAL ATTACHMENT MAJ-1990; ENDOSCOPIC MEASUREMENT DEVICE M2-3U; GENERATOR ESG-300 (WA90003W); SNAREMASTER PLUS SD-400U-10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown