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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 No Information (3190)
Event Type  malfunction  
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 failed to disengage.
 
Event Description
N/a.
 
Manufacturer Narrative
Udi: (b)(4).Perforator was returned for evaluation: dhr - all assembly process steps, cleaning, functional testing, labeling, packaging, and sterilization process steps were followed and completed with zero non-conformances.All units passed the functional requirements.Failure analysis: visual inspection: organic matter and no eto label were present.Ifu testing procedure and functional test: perforator was found to perform as intended.Perforator was found to meet all acceptance criteria.Tested within the specifications the root cause is undetermined and was unable to be confirmed in the complaint evaluation.
 
Manufacturer Narrative
Udi: (b)(4).Complaint sample was not returned for evaluation therefore; an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.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.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
 
Event Description
N/a.
 
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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 Key9152339
MDR Text Key191830207
Report Number1226348-2019-00452
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 company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/23/2019
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? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Catalogue Number261221
Device Lot NumberJ0861P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Initial Date Manufacturer Received 09/23/2019
Initial Date FDA Received10/03/2019
Supplement Dates Manufacturer Received03/04/2020
08/26/2020
Supplement Dates FDA Received07/17/2020
09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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