MAUDE Adverse Event Report: COGENTIX MEDICAL, INC. MACROPLASTIQUE; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Catalog Number MRN-420

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 05/05/2017

Event Type  malfunction  

Event Description

While performing an injection cystoscopy with injection of macroplastique, the cogentix 3.8 fr.Endoscopic needle bent while in use.

• Brand Name: MACROPLASTIQUE
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): COGENTIX MEDICAL, INC.; 40 ramland rd s; orangeburg NY 10962
• MDR Report Key: 6855023
• MDR Text Key: 85643182
• Report Number: 6855023
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MRN-420
• Device Lot Number: 57738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A 21 FRENCH CYSTOSCOPE WAS IN USE AT THE TIME. UNK; OTHER, INTRAVENOUS SEDATION
• Patient Age: 73 YR
• Patient Weight: 78