MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. INJECTORFORCE MAX; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number NM-400U-0525

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/19/2022

Event Type  malfunction  

Event Description

After removing injection needle from the package, it was discovered that the catheter was kinked in two spots and the needle could not be advanced from the catheter.

• Brand Name: INJECTORFORCE MAX
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 16378121
• MDR Text Key: 309579059
• Report Number: 16378121
• Device Sequence Number: 1
• Product Code: FBK
• 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: 12/19/2022

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 Catalogue Number: NM-400U-0525
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male