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

Model Number MAJ-339

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

Patient Problems Abdominal Pain (1685); Fever (1858); Perforation (2001); Peritonitis (2252); Malaise (2359)

Event Date 11/01/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "delayed perforation after endoscopic detachable snare ligation for colonic diverticular hemorrhage".Literature summary: a 74-year-old man was admitted to the hospital with severe hematochezia.Abdominal enhanced computed tomography (ct) demonstrated extravasation of contrast material from the descending colon.Colonoscopy revealed recent bleeding in the descending colon diverticulum.Bleeding was stopped using detachable snare ligation.The patient was discharged on the fifth day.After discharge from the hospital, the patient had no abdominal pain or hematochezia.However, on the afternoon of the seventh day, the patient developed malaise, fever, and abdominal pain.On the eighth day, the patient visited the hospital and underwent blood tests.His hemoglobin level was decreased, white blood cell count increased, and c-reactive protein level markedly elevated at 22.47 mg/dl.Ct revealed free air caused by delayed perforation.The patient was diagnosed with panperitonitis caused by delayed perforation after endoscopic detachable snare ligation (edsl).The patient underwent emergency surgery on the same day.Perforation at the ligation site was detected using intraoperative colonoscopy.Colostomy was performed at the same site.The patient was discharged from the hospital on the 30th day.This report is the first to describe a case of delayed perforation after endoscopic detachable snare ligation for colonic diverticular hemorrhage.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6).This medwatch report is for (b)(4).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information has been requested but no information was received at this time.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author (update field b5).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.

Event Description

Additional information received from the author: no olympus device cause or contribute to any of the patient adverse events described in this literature.No olympus device malfunction during any procedure described in this literature.

• Brand Name: LOOP
• Type of Device: LOOP
• 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: 18336882
• MDR Text Key: 330664085
• Report Number: 9614641-2023-01920
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male