MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS PITUITARY CLAMP; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 09/22/2016

Event Type  malfunction  

Event Description

Pituitary clamp broke during microdiscectomy surgery.No untoward effect to patient.Device was taken out of service.

• Brand Name: PITUITARY CLAMP
• Type of Device: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr.; minneapolis MN 55428
• MDR Report Key: 6173693
• MDR Text Key: 62363749
• Report Number: 6173693
• Device Sequence Number: 0
• Product Code: HAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2016
• 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
• Patient Age: 61 YR