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

Model Number	MAJ-311
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the distal cover fell off the end of the scope into the patients stomach.The cover was retrieved, and although there was a slight delay, the procedure was completed using the same device.There was no patient harm as a result of the event.Case with patient identifier (b)(6) reports the jf-260v flex video scope used in the procedure.Case with patient identifier (b)(6) reports the maj-311 distal cover used in the procedure.
Additional Manufacturer Narrative
The device was returned for evaluation and the investigation is in process.No visual defects were identified on the distal cover.However, the cover used for the procedure has been selected in error.The jf-260v device is intended for use with the maj¿411 in accordance with the instructions for use (ifus).Although the mechanism to attach the caps is identical, the maj-311 would be loose when fitted to a jf-260v, in this instance the distal end cap fell into the patient, previous experience indicates this fault is typically a result of user handling.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The investigation determined that the wrong distal cover (model maj-311) was used on the duodenoscope (model jf-260v).The maj-311 has a loose fit on the jf-260v and is incompatible.According to the instructions for use (ifu) for the jf-260v, the compatible distal cover is model maj-411.The investigation concluded that use of an incompatible distal cover was the root cause of the reported event.The reported event can be prevented by following the instructions for use (ifu) which state the following: ¿warnings and cautions: never use the endoscope unless the distal cover is properly attached to the distal end.If the distal cover is not attached properly, it may slip off or fall off the distal end during the examination.This could result in thermal injury when the endoscope is used with high-frequency endo-therapy accessories.Also, continuing the examination after the distal cover has fallen off may cause patient injury by the uncovered distal end of the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DISTAL COVER
• Common Device Name: DISTAL COVER
• 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: 13592404
• Report Number: 8010047-2022-03513
• Device Sequence Number: 14434904
• Product Code: FET
• UDI-Device Identifier: 04953170071393
• UDI-Public: 04953170071393
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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-311
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2022
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: JF-260V SCOPE (SN (B)(6)
• Patient Sex: Unknown