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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS
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RAYNHAM 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 01/11/2021
Event Type  malfunction  
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 did not stop during a craniotomy procedure.The perforator clicked in place in the drill (pneumatic anspach drill) and a spring tess were performed between each burr hole.No patient injury reported and the event did not led to surgical delay.
 
Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h10 the perforator was not returned for evaluation (as per customer, product not available) 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 additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
Event Description
N/a.
 
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Brand Name
CODMAN DISPOS PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key11273977
MDR Text Key232809419
Report Number3014334038-2021-00016
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 user facility
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number261221
Was Device Available for Evaluation? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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