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

Model Number NM-4L-1

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature titled "endoscopic submucosal dissection for large duodenal laterally spreading lesions is feasible: a multi-center retrospective study".This multicentric retrospective study sought to assess the effect and safety of esd for large laterally spreading lesions located in the descending duodenum based on multi-center experiences.A total of 51 patients were included.The average procedure time for en bloc resection ranging from 20 to 117 min (median: 45.5 min).Two patients experienced delayed bleeding 3 days after esd and 2 other patients were diagnosed with delayed perforation.All the patients were closely followed up for a median period of 16 months (range 7 to 29 months), and there were no deaths.No residual tumor and local recurrence occurred during follow-up.Esd for laterally spreading lesions of the descending duodenum is a feasible therapeutic procedure and can achieve a favorable en bloc resection rate.Type of adverse events/number of patients: delayed bleeding: case 1; delayed bleeding: case 2; delayed perforation (postoperative fever, mild abdominal pain): case 3; delayed perforation (fever, severe abdominal pain, diffuse peritonitis): case 4.This literature article requires 28 reports.The related patient identifiers are as follows: 1.(b)(6) /case1(female, 64)/kd-620lr; 2.(b)(6) /case1(female, 64)/kd-611l; 3.(b)(6) /case1(female, 64)/fg-8u-1; 4.(b)(6) /case1(female, 64)/nm-4l-1; 5.(b)(6) /case1(female, 64)/fd-410lr; 6.(b)(6) /case1(female, 64)/gif-h260; 7.(b)(6) /case1(female, 64)/maj-339; 8.(b)(6) /case2(male, 63)/kd-620lr; 9.(b)(6) /case2(male, 63)/kd-611l; 10.(b)(6) /case2(male, 63)/fg-8u-1; 11.(b)(6) /case2(male, 63)/nm-4l-1; 12.(b)(6) /case2(male, 63)/fd-410lr; 13.(b)(6) /case2(male, 63)/gif-h260; 14.(b)(6) /case2(male, 63)/maj-339; 15.(b)(6) /case3(male, 57)/kd-620lr; 16.(b)(6) /case3(male, 57)/kd-611l; 17.(b)(6) /case3(male, 57)/fg-8u-1; 18.(b)(6) /case3(male, 57)/nm-4l-1; 19.(b)(6) /case3(male, 57)/fd-410lr; 20.(b)(6) /case3(male, 57)/gif-h260; 21.(b)(6) /case3(male, 57)/maj-339; 22.(b)(6) /case4(female, 61)/kd-620lr; 23.(b)(6) /case4(female, 61)/kd-611l; 24.(b)(6) /case4(female, 61)/fg-8u-1; 25.(b)(6) /case4(female, 61)/nm-4l-1; 26.(b)(6) /case4(female, 61)/fd-410lr; 27.(b)(6) /case4(female, 61)/gif-h260; 28.(b)(6) /case4(female, 61)/maj-339.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and follow-up from the author.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.

• Brand Name: INJECTOR
• Type of Device: INJECTOR
• 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: 16721453
• MDR Text Key: 313122021
• Report Number: 9614641-2023-00489
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K011484
• 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,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NM-4L-1
• 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
• Date Manufacturer Received: 04/11/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female