MAUDE Adverse Event Report: CODMAN* DISP PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

Catalog Number 26-1221

Device Problems Cut In Material (2454); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 07/08/2012

Event Type  Injury  

Event Description

Affiliate reported that the hospital had difficulty using a total of 14 perforators, which were all reported to the sales rep on a single day.They were blunt and did not cut well.As a result it was estimated that the surgery was delayed for approximately 35 minutes.(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3771137
• MDR Text Key: 14874293
• Report Number: 1226348-2014-11423
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 26-1221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2012
• Date Manufacturer Received: 04/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention