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

Model Number MAJ-2315

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Event Description

During endoscopic retrograde cholangiopancreatography (ercp) procedure physician intubated scope into the gi tract.Once the scope was in the stomach doctor and staff noticed the ercp distal end scope cap had come loose and was in the stomach.Ercp scope removed and egd scope was intubated in the gi tract.Roth net was used to capture scope cap.Upon pulling the scope and the roth net out of the patient, scope cap was not found in the roth net.The tip slipped from the roth net in the oral cavity and could not be initially located in the oral cavity with gastroscope or palpation.Patient intubated and the tip was removed manually.

• 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: 19212838
• MDR Text Key: 341383856
• Report Number: 19212838
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Catalogue Number: N5786100
• Device Lot Number: H3118
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Race: White