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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 03/10/2019
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 that a perforator plunged and did not disengage and went through dura only.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi: (b)(4).The complaint sample was not returned to codman, therefore, an evaluation of the device could not be performed.Device history records (dhrs) were reviewed and no anomalies were found.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.
 
Event Description
N/a.
 
Manufacturer Narrative
An unused perforator from the same lot was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.No anomalies were observed as this was unused product which was returned from the same lot.Ifu testing was performed with no observed anomalies.It at first had a ¿sticky¿ hudson end, but it was freed by moving the hudson end and introducing motion.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release: the unit was found to perform as intended and fulfilled the 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.Product was received for analysis and the investigation could not confirm the complaint.
 
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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 Key8460211
MDR Text Key140173785
Report Number1226348-2019-00020
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
PMA/PMN Number
791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/30/2021
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? No
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Catalogue Number261221
Device Lot NumberJ13269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Initial Date Manufacturer Received 03/13/2019
Initial Date FDA Received03/28/2019
Supplement Dates Manufacturer Received07/18/2019
09/10/2021
Supplement Dates FDA Received07/18/2019
09/30/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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