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 Problem Insufficient Information (4580)

Event Date 05/17/2022

Event Type  malfunction  

Event Description

Ercp scope attachment came off while extracting scope.

• 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: 14591570
• MDR Text Key: 293265439
• Report Number: 14591570
• 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: 05/26/2022

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: MAJ-2315
• Device Lot Number: H1525
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Race: White