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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
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 physician reported drill bits plunged into the skull of a perforator.No patient injury reported and it is it is unknown if the device led to surgical delay.No additional information available.
 
Manufacturer Narrative
Udi: (b)(4).The perforator was returned for evaluation.Device history record (dhr) - the lot number for this complaint is unknown and was not reported by the customer, and it is not visible on the returned unit.Therefore, a dhr review is not possible.Failure analysis - the perforator units were inspected using the unaided eye.Both units had visible tool markings and worn "eo" labels that could not be read.Unit 1 had a bad weld and could not hold the sleeve, the bad weld is believed to not be a manufacturing error."ifu" testing was performed.One unit had to be re-sleeved prior to testing, the other unit was tested as is.Once the re-sleeved unit was re-sleeved, it tested as intended.The second unit performed as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The units were 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 complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
 
Event Description
N/a.
 
Event Description
N/a.
 
Manufacturer Narrative
Additional information received: this event is for two perforators: both perforators had the same failure.Both were used in the same patient.Investigation findings in follow up #1 included the analysis of both perforators.
 
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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
MDR Report Key11853123
MDR Text Key251746707
Report Number3014334038-2021-00098
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 health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 07/29/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Initial Date Manufacturer Received 04/28/2021
Initial Date FDA Received05/19/2021
Supplement Dates Manufacturer Received06/23/2021
07/08/2021
Supplement Dates FDA Received07/08/2021
07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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