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

Model Number MAJ-2315

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

The customer reports during two separate (unspecified) exams using an evis exera iii duodenovideoscope with a single use distal cover, the distal cover fell off the scope (and into the patient).During procedure 1 of 2, the distal cover could not be located to remove it from the patient.During procedure 2 of 2, the distal cover was found and retrieved from near the bite block.No additional consequences to the patients were reported as a result of these occurrences.Additional details regarding the patients and reported events were requested.The customer stated that the physician could not remember in which patient cases this occurred, and therefore no further patient event could be provided.The nurse assisting in both cases with this physician stated ¿i think it could have been my fault for not making sure the cap was secure on the tip.I now push it on and then pull on it to make sure it will not fall off.I have not had any further problems.Case with patient identifier (b)(6) reports the single use distal cover used in procedure 1 of 2 (which was not retrieved).Case with patient identifier (b)(6) reports the tjf-q190v used in procedure 1 of 2.Case with patient identifier (b)(6) reports the single use distal cover used in procedure 2 of 2 (which was retrieved).Case with patient identifier (b)(6) reports the tjf-q190v used in procedure 2 of 2.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 13601103
• MDR Text Key: 286165175
• Report Number: 2951238-2022-00323
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2022,02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2022
• Date Report to Manufacturer: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V
• Patient Outcome(s): Other