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

Model Number NM-610U-0426

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/12/2021

Event Type  malfunction  

Event Description

Olympus needlemaster single-use injection 26g needle was bent.

• Brand Name: NEEDLEMASTER
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 11869685
• MDR Text Key: 252163021
• Report Number: 11869685
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NM-610U-0426
• Device Catalogue Number: NM610U0426
• Device Lot Number: 07VA
• 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: 05/17/2021
• Date Report to Manufacturer: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24382 DA