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

Model Number	MAJ-1989
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the endoscope was incorrectly reprocessed, as the distal hood (subject device) was not removed during the reprocessing of the endoscope.The device was subsequently used on one patient.There was no adverse event associated with this reported event.
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.This report will be supplemented when the investigation is completed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to b5,h3,d8 of the initial medwatch.The device history record was unable to be reviewed for this device since the 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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to incorrect reprocessing by the user or device handling.The event can be detected by following the instructions for use (ifu) which state: -operation manual.¿4.3 using endotherapy accessories".¿chapter 4.Operation¿ 4.3 (english ver.4.2) detaching the distal hood from the endoscope if additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Attempts to retrieve additional information from the customer are in progress.Case with patient identifier (b)(6) for this reports the maj-1989 used in the procedure.Case with patient identifier (b)(6) reports the scope used in the procedure.

• Brand Name: DISTAL HOOD
• Common Device Name: DISTAL HOOD
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14366494
• Report Number: 8010047-2022-08094
• Device Sequence Number: 12172505
• Product Code: FDS
• UDI-Device Identifier: 04953170314391
• UDI-Public: 04953170314391
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: MAJ-1989
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290Z SN:(B)(6).
• Patient Age: 70 YR
• Patient Sex: Male