MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARD C- MAX CUTTING LOOP

Catalog Number 355311

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the loop broke during the procedure.The doctor was cauterizing the bladder with the loop and the loop broke during the procedure; specimen was sent to x-ray to be evaluated to see if a piece was inside, and there were no pieces seen in the specimen or the bladder.The original intended procedure was a cystoscopy; evaluation of clot with transurethral resection of bladder tumor.

• Brand Name: BARD C- MAX CUTTING LOOP
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4239178
• MDR Text Key: 19044337
• Report Number: 1018233-2014-00296
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/10/2014

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 Expiration Date: 03/30/2018
• Device Catalogue Number: 355311
• Device Lot Number: NGYF2630
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 104