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

Model Number	HX-610-090
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	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: adverse event 1 (b)(6).Adverse event 2 (b)(6).Adverse event 3 (b)(6).This mdr is for adverse event 1.Since the literature described "hx-610", olympus selected "hx-610-090" as a representative product.The product was unknown, but a representative product was chosen for processing purposes.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled "endoscopic resection of gastric gastrointestinal stromal tumor using clip-and-cut endoscopic full-thickness resection: a single-center, retrospective cohort in korea".Literature summary background/aims: to overcome the technical limitations of classic endoscopic resection for gastric gastrointestinal stromal tumors (gists), various methods have been developed.In this study, we examined the role and feasibility of clip-and-cut procedures (clip-and-cut endoscopic full-thickness resection [cc-eftr]) for gastric gists.Methods: medical records of 83 patients diagnosed with gists after endoscopic resection between 2005 and 2021 were retrospectively reviewed.Moreover, clinical characteristics and outcomes were analyzed.Adverse events: a total of 43 (51.8%) patients experienced adverse events after er (table 5).The overall rates of adverse events were higher in the cc-eftr group compared to that in the esd group (37.3% for esd vs.75.0% for cc-eftr, p=0.001).Pneumoperitoneum occurred in 13 (25.5%) and 22 (68.8%) patients in the esd and cc-eftr groups, respectively.However, only one patient in the esd group and two in the cc-eftr group progressed to localized peritonitis, however, they recovered after conservative care, including broad-spectrum antibiotic administration (2.0% for esd vs.6.3% for cc-eftr, p=0.311).Two patients underwent emergent operations during the er.In the esd group, a patient with severe bleeding during the procedure underwent emergent wedge resection.In the cc-eftr group, a patient with failed endoscopic closure for a huge transmural hole during er underwent emergent wedge resection.All other patients were managed with conservative treatment, including endoscopic closure with hemostatic clips and intravenous antibiotics, without any further adverse events.Results: endoscopic submucosal dissection (esd) and cc-eftr were performed in 51 and 32 patients, respectively.The gists were detected in the upper third of the stomach for esd (52.9%) and cc-eftr (90.6%).Within the cc-eftr group, a majority of gists were located in the deep muscularis propria or serosal layer, accounting for 96.9%, as opposed to those in the esd group (45.1%).The r0 resection rates were 51.0% and 84.4% in the esd and cc-eftr groups, respectively.Seven (8.4%) patients required surgical treatment (six patients underwent esd and one underwent cc-eftr,) due to residual tumor (n=5) and post-procedure adverse events (n=2).Patients undergoing r0 or r1 resection did not experience recurrence during a median 14-month follow-up period, except for one patient in the esd group.Conclusions: cc-eftr displayed a high r0 resection rate; therefore, it is a safe and effective therapeutic option for small gastric gists.Type of adverse events/number of patients: adverse event 1 (bleeding - female, 63).Adverse event 2 (perforation - male, 72).Adverse event 3 (fever -20 patients, pneumoperitoneum -35 patients, peritonitis -3 patients).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation and correction to d4 (udi).The device history record was unable to be reviewed for this device, since the 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, a relationship between the device and the adverse event 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: CLIP
• Common Device Name: 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: 19838976
• Report Number: 9614641-2024-01514
• Device Sequence Number: 20480229
• Product Code: PKL
• UDI-Device Identifier: 04953170200298
• UDI-Public: 04953170200298
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K240617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 09/06/2024

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-610-090
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: D-201-11804; GIF-HQ290/GIF-H260; KANEKA MEDIX RC1550-2WE; KD-611L/KD-655L/KD-620LR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female