MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number PCF-PH190L

Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979)

Patient Problem Hematoma (1884)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that when the withdrawing the colonovideoscope in a diagnostic colonoscopy procedure hematoma in the splenic flexure and sigmoid colon till the anal canal was observed.Another procedure after a few days was conducted using the same device and a hematoma and the splenic flexure was observed when withdrawing the endoscope.There was no delay in completing the procedure.Procedure was able to be completed with the same device.No additional intervention was required, however the patient was hospitalized and monitored for possible risk of bleeding.The patient is ¿under regular clinical and analytical controls¿.

Manufacturer Narrative

E1: complete establishment name is added here due to limited character space: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19007271
• MDR Text Key: 338981167
• Report Number: 9610595-2024-06710
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305238
• UDI-Public: 04953170305238
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-PH190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• 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): Hospitalization