MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. LONG CLIP

Model Number	HX-610-135L
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	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Establishment name in full: (b)(6).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.A copy of the literature is attached for review.
Event or Problem Description
Olympus reviewed a literature article titled "evaluation of a new method, "non-injection resection using bipolar soft coagulation mode (nirbs)", for colonic adenomatous lesions." this retrospective study developed a new ¿non-injection resection using bipolar soft coagulation mode (nirbs)¿ method, adapted for colorectal lesions.In addition, we evaluated the effectiveness of this method.We performed nirbs throughout a 12-month period for all colorectal lesions which snare resection was acceptable without cancerous lesions infiltrating deeper than the submucosal layer.A total of 746 lesions were resected from 375 patients.The major pathological breakdowns were as follows: 64.3% (480/746) were adenomas, and 5.0% (37/746) were intraepithelial adenocarcinomas (tis lesions).No residuals were observed in any 37 tis lesions (mean size, 15.3 mm).Type of adverse events/number of patients.This study only evaluated major adverse events such as bleeding during the procedure, delayed bleeding, and perforation.¿bleeding during the procedure¿¿profuse bleeding that occurred from the resected portion immediately after resection.¿delayed bleeding¿: a large amount of fresh bleeding or bloody stools that followed several hours after resection.Adverse events included bleeding (0.4%) but no perforation.Event1: bleeding during the procedure (age 70, male) - patient experienced major rectal bleeding during the procedure and was treated with clip-suturing, which resulted in recovery.Event2: delayed bleeding (age 39, male) - patient experienced delayed sigmoid colon bleeding treated with clip-suturing and a disposable ligation device (dld-ligation), which resulted in recovery.Event3: delayed bleeding (age 78, female) - patient experienced ascending colon bleeding treated with clip-suturing, which resulted in recovery.This article requires 10 reports as the procedure was performed using one of three scopes.The scope type was not provided for each patient, hence there is a report for each scope for each patient.The related patient identifiers are as follows: 1 - patient identifier (b)(6) (event1 age 70, male) with evis colonovideoscope.2 - patient identifier (b)(6) (event1 age 70, male) with evis lucera colonovideoscope.3 - patient identifier (b)(6) (event1 age 70, male) with evis lucera elite colonovideoscope.4 - patient identifier (b)(6) (event2 age 39, male) with long clip.5 - patient identifier (b)(6) (event2 age 39, male) with evis colonovideoscope 6 - patient identifier (b)(6) (event2 age 39, male) with evis lucera colonovideoscope.7 - patient identifier (b)(6) (event2 age 39, male) with evis lucera elite colonovideoscope.8 - patient identifier (b)(6) (event3 age 78, female) with (b)(6) evis colonovideoscope.9 - patient identifier (b)(6) (event3 age 78, female) with evis lucera colonovideoscope.10 - patient identifier (b)(6) (event3 age 78, female) with evis lucera elite colonovideoscope.This report is for patient identifier (b)(6).There was no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (updated field b3).Additionally, to provide additional information received from the author (updated field b5).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.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: LONG CLIP
• Common Device Name: LONG CLIP
• 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: 18318645
• Report Number: 9614641-2023-01896
• Device Sequence Number: 7521227
• Product Code: PKL
• UDI-Device Identifier: 04953170209154
• UDI-Public: 04953170209154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: HX-610-135L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male