MAUDE Adverse Event Report: UROPLASTY, INC. RIGID ENDOSCOPIC NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number MRN-420

Device Problem Break (1069)

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

Event Date 05/04/2021

Event Type  malfunction  

Event Description

The needle broke when attempting to inject microplastic.The needle broke outside of patient and fell onto the floor.A new needle had to be opened to complete the procedure.Broken needle had patient contact but no patient harm.

• Brand Name: RIGID ENDOSCOPIC NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): UROPLASTY, INC.; 5420 feltl road; minnetonka MN 55343
• MDR Report Key: 11884615
• MDR Text Key: 252650798
• Report Number: 11884615
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRN-420
• Device Catalogue Number: MRN-420
• Device Lot Number: 83971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA