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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC.

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CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE PERFORATOR; DRILLS, BURRS, TREPHINES & ACC. Back to Search Results
Catalog Number 26-1221
Device Problem Failure to Auto Stop (2938)
Patient Problem No Information (3190)
Event Date 11/02/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Upon completion of the investigation a follow up report will be filed.
 
Event Description
It was reported that a perforator did not disengage when it was supposed to.No reported patient harm resulted.There was no reported delay in surgery.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the unit was visually inspected utilizing unaided eye.No anomalies were observed.Unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.Complaint could not be verified.Unit was found to meet all acceptance criteria.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.
 
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Brand Name
CODMAN DISPOSABLE PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACC.
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
new bedford industrial park
new bedford MA 02745
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7067001
MDR Text Key93896983
Report Number1226348-2017-10898
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K791101
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
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 Catalogue Number26-1221
Device Lot NumberHC1863
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2017
Initial Date FDA Received11/29/2017
Supplement Dates Manufacturer Received01/03/2018
Supplement Dates FDA Received01/11/2018
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
Patient Sequence Number1
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