MAUDE Adverse Event Report: CAREFUSION TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE; RETRACTOR, FIBEROPTIC

Model Number 88-1087

Device Problem Accessory Incompatible (1004)

Patient Problem Burn(s) (1757)

Event Date 10/01/2014

Event Type  Injury  

Event Description

Sales rep stated, director of material management reported that this event occurred 6 months ago, just came to her attention as or wants to purchase another retractor.We got or instrument buyer on the phone who reported that he thinks that they used the storz cord that they have on hand, not the s-p.That was all "thet either" knew.This was not previously reported to carefusion in any way.Patient was harmed due to a burn.Additional information received 07apr2015: the sales rep reported the cord was unmarked and will be sent in along with the 88-1087.It was reported that the instrument and cord were both sent out to medical optics, a local repair company, after a reported incident approx.6 months ago.After several attempts, no further information was provided.

Manufacturer Narrative

(b)(4).If further information becomes available, a follow up medwatch will be submitted.

Manufacturer Narrative

(b)(4): one (1) 88-1087 tebbetts fiberoptic ss retractor received for evaluation a patient was harmed due to a burn.The sales rep reported that this event occurred 6 months ago and it was brought to her attention as or wants to purchase another retractor.This was not previously reported to carefusion in any way.The sales rep visited the facility on (b)(4) 2015 to gather additional information.Additional information received (b)(4) 2015: the sales rep reported the cord was unmarked and will be sent in along with the 88-1087.It was reported that the instrument and cord were both sent out to medical optics, a local repair company, after a reported incident approx.6 months ago.The 88-1087 device along with the light cord the hospital identified as used when the reported incident occurred 6 months ago were received for evaluation.The device and the light cord were visually examined by the product engineer, manufacturing engineer and quality engineer.The 88-1087 device was confirmed to be almost 3 years old and very worn at the handle as indicated by the gold plating completely worn off and the faded etching markings on the device.The returned light cord was identified as not being carefusion product and measured 5mm or greater which is an incorrect size to use for this product.The 88-1087 tebbetts retractor can only be used with a 3.5 mm size fiber optic bundle cable.The products information, ifu 26-0067 rev d states in the warning section: ¿these devices must only be used with a 3.5mm size fiber optic bundle cable.Do not use this device with a larger size cable.Failure to use the correctly sized cable will cause the metal connectors of the device / cable to become hot during use and increases the potential of a thermal burn.This device transmits high energy light.The metal connectors of the fiber optic bundle and the exposed tip may become hot during use¿.This reported customer misuse has been previously identified with the lighted tebbetts breast retractor family and a project was completed to address complaints associated with the lighted tebbetts breast retractor family related to patient burns.Also, an improved design has been implemented to prevent user error.The new design is currently being distributed for sale.A review of the device history record did not reveal any non-conformances.The device passed all acceptance criteria for release.Recommendation is for the customer to review the products information, ifu 26-0067 rev d in particular the warning, caution and processing sections for proper use, handling and care.Carefusion will continue to trend and monitor this reported issue and for this product code.

• Brand Name: TEBBETTS FIBEROPTC SS RETR 9CMX24MM BLDE
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS; 5175 south royal atlanta dr; tucker 30084
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4729823
• MDR Text Key: 16309786
• Report Number: 1038548-2015-00061
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: 88-1087
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other