MAUDE Adverse Event Report: CODMAN AND SHURTLEFF INCORPORATED INC CODMAN DISPOSABLE PERFORATOR

Lot Number GH002S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Internal Organ Perforation (1987)

Event Type  malfunction  

Event Description

The perforator malfunctioned and it did not stop at the dura.The dura was pierced by the perforator as was the pia.There was no bleeding or oozing of blood noted.Date of use: (b)(6) 2015.Diagnosis or reason for use: left frontal biopsy of tumor.

• Brand Name: CODMAN DISPOSABLE PERFORATOR
• Type of Device: CODMAN DISPOSABLE PERFORATOR
• Manufacturer (Section D): CODMAN AND SHURTLEFF INCORPORATED INC; 325 paramount drive; raynham MA 02767 0350
• MDR Report Key: 5184857
• MDR Text Key: 29928590
• Report Number: MW5057356
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial

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 Lot Number: GH002S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR