MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) ENDOSCOPIC LIGHT SOURCE

Model Number 5142.002

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

Actual device has not been returned but is currently in transit to manufacturer.Investigation/evaluation of device not yet initiated.Review of production records currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).

Event Description

Richard wolf (b)(4) was notified that during a procedure the device in question stopped and an error message displayed on screen.A back up device was not readily available and procedure stopped and rescheduled.Delay in procedure may have placed patient at risk.

Manufacturer Narrative

Follow up #1.The following sections updated/added: product problem, suspect device, all manufacturers, device manufacturers.The light projector was tested in the responsible department.No malfunctions were detected.The device logfile stores the error message avr-p1 in combination with xxx-xxx-407.According to ga-a264 chapter 5.10.6 this means an "electronic fault" on the function board with medium priority (yellow).The user has to notify the customer service.Also stored in the logfile is the error entry xxx-xxx-040 after approx.300 out of 624 operating hours.This error states (ga chapter 5.10.5 error low (turquoise)) that the initialization has failed.The user is requested to perform a device restart.If the error occurs again, the customer service must also be informed.According to logfile, this error occurred only once.Due to the error description of the customer is to assume a sporadic error, it is still questionable which malfunction / component on the e-board (funktionsboard) is responsible, especially since the error during the test in house did not occur.The e-board is replaced as a precaution.The 5142002 light source x 300 300w with the (b)(4) was posted on 19feb2014 on the sales warehouse.The production order (b)(4) consists of (b)(4) pieces.The 5142002 light source x 300 300w with the (b)(4) on 15apr2014 with delivery note no.(b)(4) was delivered to the company (b)(6).Lamp operating hours: 412h, lamp current: 412h, reset: 0, total device hours: 722h48min, device on / off: 643.The user is informed according to the operating instructions for the light projector highlight x300 51420x2, ga-a 264 / de / 2014-02 (b)(4) / pdg 13-6759 that in case of a possible device failure, an equivalent light projector must be available for therapeutic use.Possible hazards were taken into account in the risk assessment e4-1 r01 (xenon light sources) with the corresponding extent of damage and probability of occurrence and assessed with an acceptable risk.This rating is still valid considering the current case.Richard wolf (b)(4) considers this matter closed.However, in the event (b)(4) receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of (b)(4).

Event Description

Follow up #1.

• Brand Name: ENDOSCOPIC LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GERMANY (RWGMBH); registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; registration number 9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 6417335
• MDR Text Key: 70627612
• Report Number: 9611102-2017-00004
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04055207012901
• UDI-Public: 04055207012901
• Combination Product (y/n): N
• Reporter Country Code: BK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5142.002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• 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 Age: 22 YR
• Patient Weight: 55