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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
Model Number 261221
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
An investigation has ben initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported a codman disposable perforator (261221) was disassembled during surgery.All parts that fell into the surgical field were collected.Based on information provided, it is unknown if there was patient injury.No further information available.
 
Manufacturer Narrative
Codman disposable perforator was returned for evaluation.Device history record (dhr)- product 261221 with lot 5804671 was reviewed and there is an indication that the production process may have contributed to this complaint.All test results passed procedural specifications, however the 19 units scrapped at the welding step during production indicates that the manufacturing process could have contributed to the complaint condition.Failure analysis- the perforator unit was inspected using the unaided eye: unit was lightly soiled, and received disassembled, there was a shallow weld on the blue sleeve.Ifu testing procedure was performed with no observed anomalies once reassembled with the original parts the unit was returned with.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to not perform as intended with the original parts it was manufactured with, the unit plunged during testing and disassembled.The device was reassembled with a new sleeve, and then performed as intended.Root cause - the complaint was confirmed in the complaint investigation.The device did not function as was intended with the original parts it was manufactured with, and performed as intended once reassembled with new parts.The dhr review also concluded that there were 19 units scrapped in production during the welding step, and due to this, it is possible that the manufacturing process could have contributed to the complaint condition.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.
 
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
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key14687826
MDR Text Key294676220
Report Number3014334038-2022-00123
Device Sequence Number1
Product Code HBF
UDI-Device Identifier10381780513599
UDI-Public10381780513599
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/02/2022
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 Model Number261221
Device Catalogue Number261221
Device Lot Number5804671
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/26/2022
Initial Date FDA Received06/14/2022
Supplement Dates Manufacturer Received07/19/2022
Supplement Dates FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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