MAUDE Adverse Event Report: AESCULAP AG AXEL XENON LIGHT SOURCE 180W; COLD LIGHT FOUNTAINS

Model Number OP930

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on going.

Event Description

Country of complaint: (b)(6).The original fault appeared allegedly again, after the repair was carried out.The problem appears when the product is turned off after a longer application and then switched on again.The light source then does not start to work any more.The bulb was fairly often replaced.The device interestingly enough works again after it is turned off for some time (cooling?).It has happened several times while a patient was already under anesthesia in which the surgeon then could not start with arthroscopy, because of the defective device.

Manufacturer Narrative

The light source arrived without any visible damages.The light source was tested and the described failure was confirmed.For further analysis the electronic module was sent to the manufacturer.A review of the device quality and manufacturing history records was not possible because the power/ignition unit is a purchased part.According to the supplier the root cause for the behavior of the power/ignition unit was defective capacitors and ignition sparks gap.Corrective/preventive action not required.Additional information: lot number, device manufacture date.

• Brand Name: AXEL XENON LIGHT SOURCE 180W
• Type of Device: COLD LIGHT FOUNTAINS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5234114
• MDR Text Key: 31571915
• Report Number: 2916714-2015-01037
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K984124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OP930
• Device Catalogue Number: OP930
• Device Lot Number: 51389276
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/04/2015
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2007
• 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
• Patient Outcome(s): Other