MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ROTATABLE CLIP FIXING DEVICE

Model Number HX-110QR

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

This report is related to the following linked patient identifiers: (b)(4).The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.Doi.Org/10.1080/00365521.2023.2171315 for additional information.

Event Description

Olympus reviewed the following literature "underwater endoscopic mucosal resection with submucosal injection and marking' for superficial non-ampullary duodenal epithelial tumors to achieve r0 resection: a single-center case series." abstract objectives: to describe an endoscopic technique named ¿underwater endoscopic mucosal resection (uemr) with submucosal injection and marking (uemr-sim)¿ and to evaluate the therapeutic characteristics of superficial non-ampullary duodenal epithelial tumors (snadets) < 20mm vis-a-vis classical emr (cemr) and uemr techniques.Materials and methods: this retrospective study included 103 consecutive snadet patients (103 lesions) who underwent cemr, uemr, or uemr-sim.The uemr-sim procedure included (1) marking and submucosal injection, (2) filling of the duodenal lumen with 0.9% saline, (3) snaring of the lesion, and (4) electrosurgical removal.The procedural outcomes were compared between the uemr-sim and other-procedure groups.Results: the en bloc resection rate was significantly higher in the uemr-sim group (100%) than in the cemr group (76.8%) (p.0.015) but was not statistically different between the uemr-sim and uemr groups (88.0%) (p.0.236).The r0 resection rate was significantly higher in the uemr-sim group (90.9%) than in the uemr group (48.0%) (p.0.001) but was not statistically different between the uemr-sim and cemr groups (76.8%) (p.0.209).¿type of adverse events/number of patients¿ delayed bleeding (1) the delayed-bleeding case was an 8-mm flat lesion in the second portion of the duodenum in a 70-year-old man who had been taking warfarin due to atrial fibrillation.Cemr was performed with continued warfarin therapy, and the mucosal defect was completely closed.However, delayed bleeding occurred 3 and 6 days post-cemr, requiring endoscopic hemostasis twice and hospitalization for 18 days.Only one case showed a local recurrence after 32.4 months in the cemr group, whereas no local recurrences were observed in the uemr and uemr-sim groups.The local recurrence was successfully treated with salvage endoscopic mucosal dissection (esd).

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Type of Device: ROTATABLE CLIP FIXING DEVICE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18774964
• MDR Text Key: 336212737
• Report Number: 9614641-2024-00466
• Device Sequence Number: 1
• Product Code: PKL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013066
• 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
• Report Date: 02/25/2024

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: HX-110QR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COLONOSCOPE (PCF-H290TI); VIDEOSCOPE(GIF-Q260J
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male