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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number 261221
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the surgeon was drilling the patient's skull to perform an external ventricular drain and perforator proceeded without stopping like it usually does; basically it broke to several pieces then he went on to use a matchstick which is another drill bit.The procedure was completed with a replacement drill bit and the event led to 5 minutes surgical delay.
 
Manufacturer Narrative
Udi: (b)(4).The perforator was returned for evaluation: dhr- there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the perforator unit was inspected using the unaided eye.No anomalies were observed, the outer drill had heavy damage not related to manufacturing, there was organic matter and worn eto label.Ifu testing was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release 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 root cause is undetermined and was unable to be confirmed in the complaint evaluation.
 
Event Description
N/a.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA 02048
MDR Report Key10399940
MDR Text Key202990425
Report Number3014334038-2020-00018
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
Type of Report Initial,Followup
Report Date 07/24/2020
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 Catalogue Number261221
Device Lot NumberJ76F28
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Initial Date Manufacturer Received 07/24/2020
Initial Date FDA Received08/12/2020
Supplement Dates Manufacturer Received09/02/2020
Supplement Dates FDA Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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