MAUDE Adverse Event Report: AESCULAP INC FRAZIER SLOT SUCT TUBE ANG 12FR 140MM; MICRO NEUROSURGICAL INSTR.

Model Number MF498R

Device Problem Partial Blockage (1065)

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

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the frazier suction tube.During an unspecified procedure, it was noted that pieces of bone were getting stuck inside the suction tube.There was no harm to the patient nor a delay in surgery.The surgeon was able to remove the bone fragment and the operation was completed successfully.Additional information was not provided.

Manufacturer Narrative

D4: udi; d9: receipt date of device this complaint involves one frazier slot suction tube angled 12fr 140mm (part number: mf498r, lot number: unknown, qty: 1).After conducting a material and production analysis, the manufacturer determined that the product left their facility in a conforming manner.It is likely that the device was either mishandled by the end-user or altered by a third- party.There is evidence of scratches and deep nicks on the distal end of the device.This can be caused by excessive force applied to the devices (e.G., banging against a table to remove debris stuck inside the suction tubes).Alteration by a third-party to taper the devices at the distal end is also a possibility.Root cause was determined to likely be user misuse/handling.Corrective action was not deemed as necessary since there have not been any previous occurrences of this issue for this item.

• Brand Name: FRAZIER SLOT SUCT TUBE ANG 12FR 140MM
• Type of Device: MICRO NEUROSURGICAL INSTR.
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 9164127
• MDR Text Key: 167323712
• Report Number: 2916714-2019-00086
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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 Model Number: MF498R
• Device Catalogue Number: MF498R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUCTION TUBING