MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. MECHANICAL LITHOTRIPTOR

Model Number	BML-110A-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 lithotriptor used.1 of 2 related reports, the coil sheath device is referenced in reporter file no.(b)(4).
Additional 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: MECHANICAL LITHOTRIPTOR
• Common Device Name: MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10603055
• Report Number: 8010047-2020-06986
• Device Sequence Number: 3054252
• Product Code: LQC
• UDI-Device Identifier: 04953170033001
• UDI-Public: 04953170033001
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K903529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: BML-110A-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAJ-403 COIL SHEATH LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Other