MAUDE Adverse Event Report: FEMALE ROTATING COLLAR; RETRACTORS

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.

• Brand Name: FEMALE ROTATING COLLAR
• Type of Device: RETRACTORS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6794120
• MDR Text Key: 82684068
• Report Number: 1226348-2017-10596
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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 Number: 24-3171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 08/15/2017; 08/29/2017
• Supplement Dates FDA Received: 08/16/2017; 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 65