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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 Problem Component Missing (2306)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
It is not clear at this point if the device is available for evaluation. Without the device it is not possible for codman to conduct a proper investigation. Since a lot number has been provided a review of the manufacturing records will be reviewed. We anticipate that the evaluation will reveal that the device conformed to specifications prior to release. If anything otherwise is found then a follow up report will be filed. If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
 
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 the samples returned and visually inspected. 1 pattie was confirmed to be missing the string. It appears to have but cut or sliced as the welded section of the string remained on the pattie. The remaining 9 pattie samples were pull tested by a certified operator. All samples passed and were measured between 2 and 5 lbs. The manufacturing lot traveler was pulled and reviewed for lot h33029l-2. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. 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
Upon completion of the investigation it was noted that the samples returned and visually inspected. 1 pattie was confirmed to be missing the string. It appears to have but cut or sliced as the welded section of the string remained on the pattie. The remaining 9 pattie samples were pull tested by a certified operator. All samples passed and were measured between 2 and 5 lbs. The manufacturing lot traveler was pulled and reviewed for lot h33029l-2. All information on the traveler indicates that the product was produced within specifications. There were no engineering change orders or anything unusual relative to the manufacturing documentation of this lot. 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, a surgical pattie did not have the green string attached. No reported patient/user harm.
 
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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 Key6891546
MDR Text Key247443501
Report Number1226348-2017-10696
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,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number80-1403
Device Lot NumberH33029L-2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
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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