MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE INJECTOR NM; INJECTOR AND SHEATHSET

Model Number	NM-200L-0423
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature article: "transparent cap-assisted endoscopic sclerotherapy in esophageal varices: a randomized-controlled trial" by lili maa, xiaoquan huangb, jingjing lian, et al.This randomized prospective, single-center study was aimed to determine the feasibility, efficacy, and cost of performing endoscopic injection sclerosis (eis) with and without a transparent cap attached to the tip of the gastroscope.A total of 120 consecutive patients with esophageal varices with or without gastric varices were enrolled and randomized into two groups, a control (n=61) and a transparent cap-assisted (n= 59) group.The primary and secondary outcome measures were to determine whether the use of a transparent cap could reduce the use of salvage hemostasis methods while injection hemorrhage comparing to the endoscopic injection without a cap and to identify the hemorrhagic events that occurred during injection.Moreover, it also aimed to determine the convenience and the cost-effectiveness of using transparent cap-assisted endoscopy and the possibility of using this technique in clinical practice.The study reported a reduction of average injection sites in the transparent cap-assisted group compared with the control group (1.2 ± 0.4 vs.1.4 ± 0.05, p=0.000).No differences were observed for the hemorrhage that occurred during injection, and the rebleeding rate was statistically insignificant.In conclusion, transparent cap-assisted endoscopic sclerotherapy provided a clear field of vision by fixing the targeted veins.It also proved to reduce the salvage hemostasis method when bleeding occurs during sclerotherapy injection.And additionally, it is also associated with reduced numbers of injection sites and reduced cost of endoscopic therapy.The authors used two olympus devices, nm-200l-0423 and gif-h260.The authors did not specify which device was used in relation to the adverse events and therefore both will be reported.The adverse events reported were: thirty-six patients experienced hemorrhage during the injection in the transparent cap-assisted group and only in two patients balloon tamponade was used, six patients received additional injection sclerotherapy, and one patient received both balloon tamponade and sclerotherapy injection.In the control group, 31 patients had hemorrhage during injection, balloon tamponade was used in 12 patients, and five patients received additional injection sclerotherapy.The rebleeding rate 89.8% in transparent group and 93.4% in non-transparent group.This article includes two reports for the reported adverse events: patient identifier (b)(6): nm-200l-0423 patient identifier (b)(6): gif-h260 this is report 1 of 2 for patient identifier (b)(6): nm-200l-0423.
Event or Problem Description
Additional information received from the customer: the serial numbers are not available.In the author's medical opinion, the cause of the adverse event is more likely to be related to the level of technology and not the olympus device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the customer's response and author's medical opinion and the results of the legal manufacturer¿s investigation.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.The device was not returned for investigation.

• Brand Name: DISPOSABLE INJECTOR NM
• Common Device Name: INJECTOR AND SHEATHSET
• 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: 13586796
• Report Number: 8010047-2022-03443
• Device Sequence Number: 11930552
• Product Code: FBK
• UDI-Device Identifier: 04953170381966
• UDI-Public: 04953170381966
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: NM-200L-0423
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/06/2022
• 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; Other
• Patient Sex: Unknown