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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS
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RAYNHAM CODMAN DISPOSABLE PERFORATOR; DISPOSABLE PERFORATORS Back to Search Results
Catalog Number XXX-CODMAN PERFORATOR
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2020
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
1 of 3 reports.Other mfg report numbers: 3014334038-2020-00105, 3014334038-2020-00106.A facility reported the perforator did not stop drilling while performing a burr hole.The perforator clicked in place in the drill and the recommended spring tests between each burr hole were performed.No patient injury reported and the event did not led to surgical delay.
 
Event Description
N/a.
 
Manufacturer Narrative
The perforator was not returned for evaluation (discarded) 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.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DISPOSABLE PERFORATORS
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key10946028
MDR Text Key219535507
Report Number3014334038-2020-00104
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberXXX-CODMAN PERFORATOR
Was Device Available for Evaluation? No
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STRYKER CORE 2 DRILL; STRYKER CORE 2 DRILL
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