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

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vomiting (2144); Discomfort (2330)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

The maj-2315 was disposed of by the customer. The tjf-q290v is not being returned to olympus for evaluation. 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.

Event Description

The customer reported the doctor attached the tip cover (maj-2315) to the tjf-q290v and carried out the examination, which was a diagnostic endoscopic retrograde cholangiopancreatography (ercp) procedure. When the endoscope was removed from the patient's body at the end of the examination, the tip cover (subject device) fell off. The doctor did not notice that the tip cover had fallen off and ended the examination as it was. In the ward, the patient complained of discomfort in the pharynx, proceeded to vomit, and the tip cover was collected from the vomit. The tip cover was discarded by the user. There was no change in the patient's planned hospitalization period, and there was no problem with the patient's prognosis, as a result of the event. This report is being submitted for the maj-2315 (single use distal cover), under the medwatch with patient identifier (b)(6). The tjf-q290v (evis lucera elite duodenovideoscope) is being reported under the medwatch with patient identifier (b)(6).

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15977808
• Report Number: 3003637092-2022-00106
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14953170403016
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MAJ-2315
• Device Lot Number: H2225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Treatment(s): TJF-Q290V EVIS LUCERA ELITE DUODENOVIDEOSCOPE
• Patient Outcome(s): Other