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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATOR

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INTEGRA LIFESCIENCES CORPORATION CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATOR Back to Search Results
Catalog Number 26-1221
Device Problems Mechanical Problem (1384); Failure to Auto Stop (2938)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
 
Event Description
It was reported that the neurosurgeon used a perforator to perforate the cranium of the patient.The perforator not disengage, once the perforation was accomplished and opened the duramater but did not touch the brain.There were no consequences for the patient and no delays in the procedure.The electric medtronic drill was used with the perforator.The drill speed was 70 000 pp.The target site was used was on the posterior fossa.The bone was thin and the bone quality was normal dense.There were no underlying issues to cause an increased icp.The perforator was held perpendicular to the bone during use.The perforator was re-processed for 3 holes.The perforator will be returned for evaluation.
 
Manufacturer Narrative
Multiple attempts to obtain additional information were not successful.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
 
Event Description
Neurosurgeon used 1 perforator to perforate the cranium of the patient; the perforator not disengage once perforation was accomplished and open the duramater but did not touch the brain.No consequences for the patient.There was no delays in the procedure and no surgerical delays over 30 minutes.The electric medtronic drill was used with the perforator.The drill speed was 70,000 pp.The target site used was on the posterior fossa.The bone was thin and the bone quality was normal dense.There were no underlying issues to cause an increased icp.The perforator was held perpendicular to the bone during use.The perforator was re-processed for (b)(4) holes.
 
Manufacturer Narrative
Product was returned to johnson & johnson for failure analysis, and the following was performed on the returned unit: the perforator unit was visually inspected and no anomalies were observed other than slight wear to the product label.Ifu testing was performed with no observed anomalies.Testing included: · applying adequate pressure on the perforator point, ensuring engagement occurs as the hudson end is rotated.· when engagement occurs, placing thumb pressure on the perforator point to ensure a smooth, positive spring action.· ensuring the hudson end rotates smoothly within the perforator body when the unit is in the disengaged position.Functional testing was performed using the same protocol the unit underwent at finished goods testing prior to release.The unit was found to perform as intended, and passed acceptance criteria, which includes evaluation of the disengagement feature and any erratic or poor cutting action.In the failure analysis performed, the returned unit was found to meet all acceptance criteria.The failure analysis report is attached as supporting documentation.The complaint could not be verified through failure analysis.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATOR
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION
1000 campus drive
princeton NJ 08536
MDR Report Key8379955
MDR Text Key137510831
Report Number1226348-2019-10152
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number26-1221
Device Lot NumberJ10R75
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Initial Date Manufacturer Received 02/15/2019
Initial Date FDA Received02/28/2019
Supplement Dates Manufacturer Received03/25/2019
02/15/2019
Supplement Dates FDA Received03/27/2019
02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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