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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID

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CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE PADDIE, COTTONOID Back to Search Results
Catalog Number 80-1403
Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)
Patient Problem No Information (3190)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that after the task of replenishing cottonoid, x-ray monofilament, green string or any maintenance work, the machine will produce one pattie. The reason it does this is to prime the line with material and for the operator to review the part being made. This first part is scrapped by the operator and the machine is ready to start making stacks of 10. The only time a stack can have more than 10 is in this situation when the operator doesn¿t remove that first piece. The only time the machine can make a piece without the green string or blue monofilament is at this time. The operator has been informed and retrained about this issue. The hybrid machines are designed only to produce a stack of 10 patties at a time. The only time it will not produce a stack of 10 patties is right at the beginning when the machine will produce 1 pattie to verify the machine is operating properly and if the machine is interrupted in the middle of a cycle. Operators are trained to discard all stacks that are interrupted and any patties produced at the startup of the machine. A tcr and ilc were opened to retrain the operators that produced this lot in question. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
As reported by the ous affiliate, in a 10-pk of surgical patties, 11 were found. The extra pattie lacked the radio opague string. New product was used to complete the procedure. There were no delays or adverse consequences reported.
 
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Brand NameCODMAN SURGICAL PATTIE
Type of DevicePADDIE, COTTONOID
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6906964
MDR Text Key247447488
Report Number1226348-2017-10721
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1403
Device Lot NumberHS2044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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