MAUDE Adverse Event Report: CAREFUSION, INC FIBER-OPTIC LIGHT CABLE ACMII/ACMI 7.5FT; LIGHT, SURGICAL, FIBEROPTIC

Model Number 88-9728

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer sent in additional products with sample from another record which reported a {retractor became so hot that 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.I have included the light source and connector for inspection.} this record was created to capture the additional products sent.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 the supplier, reported the product was not made by them.This reflects the new aware date, as now this became known as a self-manufactured product.

Manufacturer Narrative

(b)(4): one (1) 88-9728 fiber-optic light cable acmii/acmi 7.5ft was returned as the light source that was utilized when the incident occurred with a retractor became so hot that it burned the patient's skin under mdr complaint (b)(4).The returned retractor and light source (this complaint) was investigated by the product engineer and quality engineer who confirmed the reported failure.The 88-9728 fiber optic light cable was visually examined by the product engineer and quality engineer.The 88-9728 device was confirmed to be 10 years old.Although the lighted cable was old it was still functioning as intended with very little interruptions (lighted breaks) in the cable.As observed and identified in the investigation for the returned 88-1086 tebbetts breast retractor under mdr complaint (b)(4), 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 returned tebbetts retractor can only be used with a 3.5 mm size fiber optic bundle cable.The products information, ifu (b)(4) 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 august 20, 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 a project and corrective action preventative action were 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 the corrective action preventative action, 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 (b)(4) 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 (b)(4) 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: FIBER-OPTIC LIGHT CABLE ACMII/ACMI 7.5FT
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6827823
• MDR Text Key: 83939247
• Report Number: 1038548-2017-00139
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901035
• 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: 10/02/2017

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 Model Number: 88-9728
• Device Catalogue Number: 88-9728
• Device Lot Number: 800302
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2007
• 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