MAUDE Adverse Event Report: CAREFUSION, INC TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDE; RETRACTOR, FIBEROPTIC

Model Number 88-1086

Device Problem Temperature Problem (3022)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Should any additional information be obtained for this issue a follow up emdr will be submitted.

Event Description

The customer reported, the retractor became so hot it burned the patient's skin.The failure occurred during patient use and caused patient harm, skin burn, no medical intervention and no user harm.On (b)(6) 2017 the sale rep reported, during use, when the retractor was touching skin, the skin was becoming red, the retractor was hot and the connector to the light source was hot.On (b)(6) 2017 although requested, no additional information was received from the customer.

Manufacturer Narrative

(b)(4).One (1) 88-1086 tebbetts fiber optic ss retractor was returned for evaluation.The customer also returned the light source that was used when the incident occurred under complaint (b)(4).The returned retractor and light source (fiber optic light cable) was investigated by the product engineer and quality engineer who confirmed the reported failure.The 88-1086 device along with the light cord the hospital identified as used when the reported incident occurred were received for evaluation.The device and the light cord were visually examined by the product engineer and quality engineer.The 88-1086 device was confirmed to be over 5 years old and very worn at the handle as indicated by the gold plating wearing off and the faded etching markings on the device.The returned light cord was identified as being bd (formerly carefusion) product and measuring 5mm which is an incorrect size to use for this product.The 88-1086 tebbetts retractor can only be used with a 3.5 mm size fiber optic bundle cable.The products information, ifu 26-0067 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¿.In addition, on (b)(6) 2012 safety reminder letters went out to customers that recently purchased these devices to reinforce this important information.This reported customer misuse has been previously identified with the lighted tebbetts breast retractor family and project and a capa was completed to address complaints associated with the lighted tebbetts breast retractor family related to patient burns and an improved design has been implemented to prevent user error.The new design was implemented on november 25, 2014.A review of the device history record did not reveal any non-conformances.The device passed all acceptance criteria for release.Conclusion(s): customer-misuse - the customer used the wrong cable size.Per a capa probable root cause: user error was the root cause of all the incidents in which the customer provided information or a returned sample was available for evaluation.The clinicians were using the retractors improperly and not following one or more of the directions found in the ifu resulting in areas of the device becoming hot enough to cause minor burns.The current device design is such that improperly sized light cables, improper cleaning, overuse of the light source and other factors may cause the device to become hot.The products information, ifu 26-0067 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¿.Recommendation is to review the products information, ifu 26-0067 in particular the warning, caution and processing sections for proper use, handling and care.Bd will continue to trend and monitor this reported issue and for this product family.

• Brand Name: TEBBETTS FIBEROPTC SS RETR 9CMX30MM BLDE
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 5175 south royal atlanta dr; tucker GA 30084
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6774654
• MDR Text Key: 82112162
• Report Number: 1038548-2017-00134
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-1086
• Device Lot Number: 843939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1