MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-11804

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 07/08/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.Received a literature titled "predictive factors for the outcome of unsupervised endoscopic submucosal dissection during the initial learning curve with prevalence-based indication".This retrospective study analyzed possible predictors for effectiveness and safety outcome parameters during the initial learning curve.A total of 480 esds were enrolled.Ebr was achieved in 84.5% (394/466) of technically successful resections.Multivariable logistic regression analysis revealed pl as negative independent predictor (or 0.27 [0.13¿0.57], p<0.001) and interventions in the esophagus (or 7.80, p<0.001), stomach (or 5.72 [2.36¿13.89], p<0.001), and rectum (or 2.29, p=0.007) as positive independent predictors for ebr.Complications occurred in 9.5% (8/84) of esophageal, 13.3% (15/113) of gastric, 16.0% (29/181) of rectal, and 15.8% (16/101) of colonic esds.There were 14/480 (2.9%) resections that were technically unsuccessful.Complications and fibrosis/pretreatment mainly caused technical failure.In conclusion, during the initial learning curve of an unsupervised esd program with prevalence-based indication, pretreated lesions and colonic esds should be avoided.In contrast, lesion size and organ-based localizations have less predictive value for the outcome.Type of adverse events/number of patients.Event 1:bleeding (27) including patient#2,4,13 in table 4.Event 2:perforation (41) including patient #3,6,7,11,12,14 in table 4.Complications occurred in 14.2% (68/480) of the cases with 27 (5.6%) bleedings and 41 (8.5%) perforations (table 2).Therapy of bleeding was conservative in 14.8% (4/27) and endoscopic in 85.2% (23/27) per patient.Therapy of perforation was conservative in 9.8% (4/41), endoscopic in 75.6% (31/41), and surgical in 14.6% (6/41) of the cases this event requires thirty (30) reports.The patient identifiers are as follows: 1.(b)(6): kd-650q, for non-identified patients.2.(b)(6): kd-620qr, for non-identified patients.3.(b)(6): d-201-11804, for non-identified patients.4.(b)(6): kd-650q, for patient#2 (age 78/sex m) in table4.5.(b)(6): kd-620qr, for patient#2 (age 78/sex m) in table4.6.(b)(6): d-201-11804, for patient#2 (age 78/sex m) in table4.7.(b)(6): kd-650q, for patient#3 (age 68/sex f) in table4.8.(b)(6): kd-620qr, for patient#3 (age 68/sex f) in table4.9.(b)(6): d-201-11804, for patient#3 (age 68/sex f) in table4.10.(b)(6): kd-650q, for patient#4 (age 49/sex m) in table4.11.(b)(6): kd-620qr, for patient#4 (age 49/sex m) in table4.12.(b)(6): d-201-11804, for patient#4 (age 49/sex m) in table4.13.(b)(6): kd-650q, for patient#6 (age 51/sex f) in table4.14.(b)(6): kd-620qr, for patient#6 (age 51/sex f) in table4.15.(b)(6): d-201-11804, for patient#6 (age 51/sex f) in table4.16.(b)(6): kd-650q, for patient#7 (age 66/sex f) in table4.17.(b)(6): kd-620qr, for patient#7 (age 66/sex f) in table4.18.(b)(6): d-201-11804, for patient#7 (age 66/sex f) in table4.19.(b)(6): kd-650q, for patient#11 (age 66/sex m) in table4.20.(b)(6): kd-620qr, for patient#11 (age 66/sex m) in table4.21.(b)(6): d-201-11804, for patient#11 (age 66/sex m) in table4.22.(b)(6): kd-650q, for patient#12 (age 72/sex f) in table4.23.(b)(6): kd-620qr, for patient#12 (age 72/sex f) in table4.24.(b)(6): d-201-11804, for patient#12 (age 72/sex f) in table4.25.(b)(6): kd-650q, for patient#13 (age 92/sex m) in table4.26.(b)(6): kd-620qr, for patient#13 (age 92/sex m) in table4.27.(b)(6): d-201-11804, for patient#13 (age 92/sex m) in table4.28.(b)(6): kd-650q, for patient#14 (age 74/sex m) in table4.29.(b)(6): kd-620qr, for patient#14 (age 74/sex m) in table4.30.(b)(6): d-201-11804, for patient#14 (age 74/sex m) in table4.This report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

E1 establishment name: (b)(6).Since the literature described "standard olympus cap" olympus selected "d-201-11804" as representative product.The product was unknown, but a representative product was chosen for processing purposes.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 event cannot be confirmed.There was no complaint reported on the subject device and 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: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• 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: 18028769
• MDR Text Key: 326915843
• Report Number: 9614641-2023-01607
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K984358
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-201-11804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention