MAUDE Adverse Event Report: AESCULAP KERRISON; RONGEUR, POWERED

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/08/2017

Event Type  Injury  

Event Description

Neurosurgeon was using the number three kerrison instrument during a surgical procedure, a screw came loose on the kerrison and fell into the spinal cord.Neurosurgeon had to dig around in the opening with the suction and cst used a forcep to quickly grab it before it went into the neptune.No harm was done to the pt and instrument was reported.

• Brand Name: KERRISON
• Type of Device: RONGEUR, POWERED
• Manufacturer (Section D): AESCULAP
• MDR Report Key: 7112090
• MDR Text Key: 94811435
• Report Number: MW5073932
• Device Sequence Number: 1
• Product Code: HAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR