MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CRANIOTOMY KIT; DISPOSABLE PERFORATORS

Catalog Number 261230

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the perforator failed to disengage during a procedure for insertion of stimulating electrodes causing extra dural bleeding treated with "floseal" glue.The medical staff managed to complete the surgery.

Manufacturer Narrative

Dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Perforator was received for evaluation: failure analysis: the perforator unit was inspected using the unaided eye.Unit was lightly soiled and had damaged/illegible eo label, no additional anomalies.Ifu testing was performed with no observed anomalies.Functional testing was performed and the unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: CRANIOTOMY KIT
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• MDR Report Key: 11026955
• MDR Text Key: 222014848
• Report Number: 3014334038-2020-00119
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K073336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261230
• Device Lot Number: J8830A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR AESCULAP GD685; MOTOR AESCULAP GD685