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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 Failure to Auto Stop (2938)
Patient Problem Tissue Damage (2104)
Event Date 03/15/2019
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported by the ous affiliate that auto release did not work and the injury to the dura occurred when the surgeon used the perforator.No further information was provided by the hospital.
 
Manufacturer Narrative
Udi: (b)(4).The device was returned for evaluation.The perforator was visually inspected utilizing an unaided eye.No anomalies were observed.A series of holes were drilled per the test method without issue.The root cause for the complaint failure cannot be confirmed.Complaint was not related to the working functionality of the product.Unit was found to meet all applicable acceptance criteria.
 
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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 Key8456212
MDR Text Key140004760
Report Number1226348-2019-00008
Device Sequence Number1
Product Code JXG
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
Type of Report Initial,Followup
Report Date 03/18/2019
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? No
Device Operator Health Professional
Device Catalogue Number261221
Device Lot NumberJ1158G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Initial Date Manufacturer Received 03/18/2019
Initial Date FDA Received03/27/2019
Supplement Dates Manufacturer Received08/05/2019
Supplement Dates FDA Received08/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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