MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISTAL ATTACHMENT

Model Number	MH-588
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time.However, the ¿inspecting the instrument¿ 3.3 inspection section of the ifu states the following: make sure that there are no scratches, cracks, or chips in the instrument.Make sure that there are no deformations, sharp protrusions, sharp edges or any other apparent irregularities.Confirm that the instrument appears exactly as shown in the tables in section 2.2, ¿specifications¿ and is not damaged.Confirm that there is no peeling or looseness at the joint.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the distal cap detached from the scope and fell inside the patient.The device component was retrieved.It is unknown if the intended procedure was completed.There was no patient injury reported.

• Brand Name: DISTAL ATTACHMENT
• Common Device Name: DISTAL ATTACHMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8167140
• Report Number: 2951238-2018-00765
• Device Sequence Number: 2142397
• Product Code: FDS
• UDI-Device Identifier: 04953170047879
• UDI-Public: 04953170047879
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MH-588
• Device Catalogue Number: MH-588
• Device Lot Number: 81K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1