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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 Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 04/01/2020
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
A facility reported the perforator did not disengage going beyond the intended depth causing damage to the cortical surface.The unit was used in a craniotomy with a drill from a competitor.The event led to 5 minutes surgical delay and the surgery was completed successfully.
 
Manufacturer Narrative
Unique device identifier (udi) - (b)(4).The perforator was received for evaluation.Dhr - there is no indication that the production process may have contributed to this complaint failure analysis- product was visually inspected; worn "eto" label and organic matter was found.The perforator was found to meet all acceptance criteria, testing within specifications.The complaint could not be verified.The root cause cannot be determined given the functional testing found the 261221 perforator met 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 Key10280151
MDR Text Key202575279
Report Number1226348-2020-00200
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 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue Number261221
Device Lot NumberJ3318D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Date Manufacturer Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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