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

Catalog Number 26-1221

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

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).We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4).A follow-up is being generated because of the medwatch is being reclassified from malfunction to serious injury.

Manufacturer Narrative

Additional information: we recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013.Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files.(b)(4).In addition, a new complaint of (b)(4) was generated as additional follow-up reports could no longer be generated in the old system.Please refer to complaint (b)(4).A follow-up is being generated because of the medwatch is being reclassified from malfunction to serious injury.

• Type of Device: DRILLS, BURRS, TREPHINES & ACC.
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3770748
• MDR Text Key: 4360664
• Report Number: 1226348-2014-11424
• 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