MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE DISTAL COVER; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number MAJ-2315

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Cough (4457)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

Patient had and endoscopic retrograde cholangiopancreatography (ercp) done on day one for stent retrieval completed with a new olympus scope that required a disposable end cap to be placed on the tip of the scope prior to procedure.The gastrointestinal (gi) tech placed the disposable end cap onto the scope and handed off the scope to be checked by the proceduralist before insertion.At the end of the procedure after scope withdrawal and after extubation, anesthesia noted that patient had higher peak pressure volumes with increased secretions.The patient began to cough, and she coughed out the disposable olympus end cap.She was monitored in the procedural room before being to gidc recovery and then return to the floor.No further complications were reported and the patient was discharged home on the next day.Manufacturer response for disposable endoscopic end cap, (brand not provided) (per site reporter).The olympus team have reported that they are sending the event forward to their quality division for review.The reps, have come to the hospital to provide educational in-services to the staff.A rep will also be present during a upcoming procedure to observe/coach the proceduralist who preform the ercp procedures.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15416949
• MDR Text Key: 299867355
• Report Number: 15416949
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/07/2022,08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: Black Or African American