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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FEMALE ROTATING COLLAR; RETRACTORS

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FEMALE ROTATING COLLAR; RETRACTORS Back to Search Results
Catalog Number 24-3171
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 05/23/2017
Event Type  Injury  
Manufacturer Narrative
Udi: product made prior to compliance date, udi unavailable; product discontinued upon completion of the investigation a follow up report will be filed.
 
Event Description
It was reported that the surgeon was performing exchange of right tissue-expander for smooth round gel implant, right capsulotomy, draining of right latissimus dorsi flap donor site seroma, left breast augmentation for symmetry.At end of procedure when drapes were removed, a superficial 1cm x 3cm second-degree burn on left upper abdominal wall noted.The connector for the lighted retractor was somewhat hot.Antibiotic ointment and nonstick gauze and occlusive dressing applied and physician and or manager disclosed incident to patient.No further mention of burn/wound on discharge documentation or subsequent history and physical assessments.Codman lighted retractor, handle - af1 # 02264 003393; cord# 073385; connector # 243171 and #030719474-001.
 
Manufacturer Narrative
Device was returned for evaluation.Upon completion of the investigation, a followup report will be filed.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that it is possible that connector of a lighted retractor gets hot from the light physics point of view.User has to be aware of that fact and control the light source power appropriately to avoid this condition.In addition it is users responsibility to avoid direct contact with light source connector.Note: this product was discontinued 2005 and was manufactured in july 2003.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
FEMALE ROTATING COLLAR
Type of Device
RETRACTORS
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6794120
MDR Text Key82684068
Report Number1226348-2017-10596
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number24-3171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/28/2017
Initial Date FDA Received08/15/2017
Supplement Dates Manufacturer Received08/15/2017
08/29/2017
Supplement Dates FDA Received08/16/2017
09/11/2017
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient Weight65
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