MAUDE Adverse Event Report: QED INC MAXENON XI 300; LIGHT, SURGICAL, FIBER OPTIC

Model Number 3010

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

While performing mastectomy, surgeon used lighted retractor with storz light cord that was attached to light source.A few minutes later, burning smell came from light source and light cord.Tip of light cord where it was plugged into light source looked burned.What was the original intended procedure: bilateral mastectomy and reconstruction with breast expander.Device usage problem: device malfunction-that is, the device did not do what it was supposed to do.

Manufacturer Narrative

Device #2.Illuminator, fiber optic, surgical field.Brand name: storz bfw illuminator, age of device: do not know, single use device: no, serial #(b)(4), model#: bfw 3010, returned to mfr: no, available for evaluation: yes, procode: unk.The maxenon xi 300, x/n (b)(4) was sold(b)(4) 20 07 to bfw inc an has no history of complaints or repairs performed at the manufacturer facility.It is designed with an intended use as a fiber optic headlight system.The description of the event/problem states that the device was being used in a surgical procedure with a lighted retractor, which is not the intended use of the device.The report states that the device was subjected to evaluation and testing on (b)(6) 2014.The evaluation says the fiber optic cable used in the procedure was from an unknown manufacturer.The findings listed in the report verify that there were no malfunctions of the power supply or internal wiring.When connected to a bfw headlight and cable, it ran for three hours with no problems.The manufacturer agrees with the test lab regarding possible contributing factors.The maxenon xi operation manual states that the fiber optic cable must be rinsed free of soaking/disinfectant solution and dried before plugging into a port.Bfw inc recommends fiber optic cables made by the original manufacturer as identified on the port turret.Refurbished cables may malfunction resulting in damage to the light source and/or cable.If using the light source with a non-bfw product, it is the user's responsibility to assure the compatibility.The medwatch report leads the manufacturer to conclude that the device wasn't used as intended by the device design.A fiber optic cable failure caused the problem.The use facility failed to adhere to warnings and recommendations in the operation manual.

• Brand Name: MAXENON XI 300
• Type of Device: LIGHT, SURGICAL, FIBER OPTIC
• Manufacturer (Section D): QED INC; 750 enterprise dr.; lexington KY 40510
• Manufacturer (Section G): BAUSCH & LOMB, INC.; 1400 north goodman st.; rochester NY 14606
• Manufacturer Contact: ira cooper ; 750 enterprise dr.; lexington, KY 40510 ; 8592310338
• MDR Report Key: 4040147
• MDR Text Key: 4862316
• Report Number: 1037039-2014-00001
• Device Sequence Number: 1
• Product Code: FST
• 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: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3010
• Device Lot Number: 30-
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR