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

Model Number MAJ-2315

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp. (omsc) was informed from the user that the 3 instances of unexpected healthy mucosa shearing/tearing off by the single use distal cover. The first case, following an endoscopic retrograde cholangiopancreatography (ercp) the endoscope had been suctioned, and then on inspection in the cleaning room a lump of tissue was found in the distal end of the endoscope. The medical staff were notified and inspected it. But the medical staff did not feel need to perform the reprocedure to look for the patient's injury. The second case, the user found a small piece of tissue in the distal end of the endoscope after removing the single use distal cover prior to suctioning. It was mixed with stone debris retrieved by ercp which was with it and some blood and mucous. The user did not alert anyone as was unsure it was not stone debris and did not think it was particularly out of the ordinary. The third case, the evis 190 series duodenoscope was used to visualize the ampulla following a gastroscopy. When the endoscope was removed after the procedure there was 4 significant pieces of tissue embedded in the single use distal cover and around the forceps elevator channel. The tissue appeared like sheared off smooth mucosa. The longest piece was nearly 20 mm long when straightened out, and the 3 other pieces were about 3x5 mm. The user completed the procedure. There has not been any bleeding or pain issues for the patient and they were discharged home. The user had inspected the single use distal cover and could not see any visual defect or protruding plastic. The user facility did not provide other detailed information. According to the number of the adverse events, omsc is submitting three medical device reports. This is 2 of 3 reports.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10903734
• Report Number: 8010047-2020-09453
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Outcome(s): Other