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

Model Number MH-463

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

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

Event Date 08/27/2021

Event Type  Injury  

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 Description

Olympus reviewed the following literature titled, "efficacy of single-balloon overtube for endoscopic submucosal dissection in the proximal colon: a propensity score-matched analysis".Objectives: a single-balloon overtube (sbo) can improve poor scope operability during colonic endoscopic submucosal dissection (esd).We aimed to evaluate the clinical usefulness of sbo for esd in the proximal colon and the predictive factors for cases in which sbo is useful.Methods: a total of 88 tumors located in the proximal colon resected by balloon-assisted esd (ba-esd) using sbo and 461 tumors resected by conventional esd (c-esd) between june 2015 and november 2020 were considered.Seventy-eight tumors each in the ba-esd and c-esd groups were matched by propensity score matching.Esd outcomes were compared between the groups, and a decision tree analysis was performed to explore the predictive factors for cases in which sbo is useful.Results: there were no significant differences between the groups in the major outcomes such as en bloc resection rate (95% vs.99%, p = 0.17), r0 resection rate (92% vs.96%, p = 0.30), mean dissection speed (16 mm2/min vs.16 mm2/min,p = 0.53), and intraoperative perforation rate (5% vs.6%,p = 0.73).Even when considering cases with poor preoperative scope operability, there were no significant differences between the groups.Comparison of tumors =40 mm in diameter between the groups confirmed that the intraoperative perforation rate was significantly lower in the ba-esd group than in the c-esd group (0% vs.24%, p = 0.0188).Conclusion: sbo is useful for esd of tumors =40 mm in diameter in the proximal colon to prevent intraoperative perforation, which usually has a long procedure time.Type of adverse events/number of patients.Intraoperative perforation (ba-esd) (4 patients).Intraoperative perforation (c-esd) (5 patients).Delayed perforation (ba-esd) (1 patients).Postoperative bleeding (ba-esd) (3 patients).Postoperative bleeding (c-esd) (1 patients).Preoperative scope operability (poor) (27+249 = 266).Scope operability (poor) (3+130 = 133).This literature article requires 9 reports.The related patient identifiers are below.The following reports are for the adverse events: (1) c23173087 colonoscope (pcf-q260azi).(2) c23173090 colonoscope (pcf-h290ti).(3) c23173091 standard tip hood (mh-463 as distal attachment).(4) c23173092 dualknife (kd-655l as single use electrosurgical knife kd-650).(5) c23173093 dualknife j (kd-655q as single use electrosurgical knife kd-655).(6) c23173094 tknife nano (kd-612q as single use electrosurgical knife kd-612).(7) c23173096 sbo (st-cb1).In addition, the following reports are for the "scope operability (fair)" scope malfunction.(8) c23173098 pcf-q260azi (iuc gib bending manipulation and insertion tube defects).(9) c23173100 pcf-h290ti (iuc gib bending manipulation and insertion tube defects).This medwatch report is for patient identifier (b)(6).

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 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: DISTAL ATTACHMENT
• Type of Device: 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: 16855902
• MDR Text Key: 314410854
• Report Number: 9614641-2023-00590
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170047756
• UDI-Public: 04953170047756
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: MH-463
• 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
• Initial Date Manufacturer Received: 04/02/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/25/2023
• 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): Other