MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. COIL SHEATH

Model Number MAJ-403

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The reported device has not yet been received for evaluation by olympus.The cause of the reported event could not be determined at this time.However, if the device is returned at a later date or if additional significant information becomes available, this report will be updated accordingly.

Event Description

Olympus was informed that during an unspecified procedure, the endoscopic scope and jag wire inserted for the intended procedure.The jag wire fed through olympus sheath and into the handle.The sheath connected to handle and screwed into place.The wire tightened in order to advance to upper gi (gastrointestinal).During the retrieval of the wire and scope from the stomach, the staff noticed the patient "hemorrhaging" from the mouth.This report is in reference to the coil sheath used.2 of 2 related reports, the lithotriptor device is referenced in reporter file no.(b)(4).

Manufacturer Narrative

This is report is being supplemented to provide additional information based on the legal manufacturer¿s investigation.According to the legal manufacturer since the device lot number was not provided, the dhr for over the past year prior to the date occurrence was inspected.No abnormalities found in the dhr of the following items, which relate to the reported phenomenon.Content of the instruction manual was confirmed; however, it did not contain the description related to the reported event.The event description indicated that the staff noticed patient ¿hemorrhaging¿ from mouth during the retrieval of the wire and scope from the stomach.However, this product is designed to be used after the scope has been removed.Therefore, it is determined that the subject device did not affect the bleeding.Therefore, the exact cause of the reported event could not be identified.Although, the root cause of the reported event could not be determined, olympus will continue to monitor trends and take appropriate actions as necessary.

• Brand Name: COIL SHEATH
• Type of Device: COIL SHEATH
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10603035
• MDR Text Key: 209135910
• Report Number: 8010047-2020-06987
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170033025
• UDI-Public: 04953170033025
• Combination Product (y/n): N
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAJ-403
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LITHOTRIPTOR MODEL BML-101-1 LOT NUMBER UNKNOWN
• Patient Outcome(s): Other