MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOLIGHT; LIGHT SOURCE LED 2.2 80W

Model Number 5164001

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Manufacturer Narrative

Rwmic (importer) is submitting this report on behalf of richard wolf, the device manufacturer.Richard wolf considers this mdr open.Richard wolf will submit a follow up report after the device evaluation has been completed and/or new information becomes available.

Event Description

It was reported to richard wolf that "or personnel detected an electrical burning odor in room.Biomed pin pointed the location of the smell and thought it was coming from the camera box.Biomed stripped and rechecked the electric wiring and found the problem was coming from the light source." "update: smoke was detected upon breakdown of or room." through email, the following information was provided: ((b)(6) 2022): no impact to the patients.Each case was completed as usual! smoke was detected upon breakdown of or room.((b)(6) 2022): from my understanding we have disregarded the camera box and it is still in use.Later that same day we found out it was the light source rather than the camera box itself.So no need for the camera box complaint.((b)(6) 2022): sn (b)(4) logic 4k camera controller.Or personel detected an electrical burning oder in room and biomed pin pointed the location of the smell and it was coming from the camera box.((b)(6) 2022) it's the lightbox that's a problem and not the camera box so how can we get this worked out?.Biomed has just stripped and rechecked the electrical wiring and found that it is indeed the light box.A loaner was sent to the user facility.Will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? no.Was there any injury or illness to the patient due to the reported issue? n/a.Was there any injury or illness to any other personnel due to the reported issue? n/a.Did the issue cause a delay in the procedure being performed? n/a.Did the delay put the patient at risk? n/a.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? n/a.

Manufacturer Narrative

Follow-up report #1 is to provide fda with new and updated information.Rwmic considers this mdr open.Should rw receive new information (results device investigation), a follow-up report will be submitted.

Event Description

The initial reporter was contacted for further information about the device malfunction.Question asked: - date of the event: response: 4/29/22.- was device serviced/repaired by a third party: not answered.- what other devices (concomitant) were being used during the procedure: not answered.

Event Description

Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device product history evaluation.

Manufacturer Narrative

Richard wolf medical instruments corporation is the importer of this device.Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Follow-up report #2 is to provide fda with the results of the device product history evaluation about this mdr.New information: the following fields have new information: d4 (udi #), h6 (type of investigation, investigation findings).Corrected information: d2 (product code).Patient information: no patient information was collected as device was not being used on a patient when the reporting issue occured.Device return status: device has not been returned as user facility claimed that the device was discarded.In lieu of the device not being returned, rwmic issued a request to richard wolf gmbh (manufacturer) for a device product history evaluation to be performed.Form 5253 (00), date: 9/2/2022.The results of the device product history evaluation: form 5253 (00), date: 9/6/2022.The reported device 5164001 with the serial number: (b)(6) was produced on 04/30/2019.The device was delivered to rwmic on 07/03/2019 and to the end user on 07/19/2019.There are no further entries of the device available.According to the user facility, the device won't be returned for investigation, so it is not possible to determine the root cause of the reported issue.The user is advised in the relevant ifu ga-a 307 / en-us / 2017-01 v2.0 / eco 2016-0316 to check the device for any damage before and after each use in section 4 checks as well as to switch off the led if it not in use in section 5.3 operation of the light source.Also, there is a safety notice about the maintenance interval in section 7.2.1 maintenance intervals.Rw gmbh has received in total 21 complaints regarding the device 5164001 in the time period of 01/01/2019 and 04/29/2022 (received the current complaint: (b)(4).There are 3 complaints that rw gmbh has received from rwmic including the current one.(b)(4).There is 1 complaint: (b)(4), that rw gmbh has no record.However, device was evaluated by rwmic due to an ethernet port not active and the results of evaluation showed no device problem found.In general, there is no previous complaint which claims the same issue with electrical burning odor.There are 9 complaints where no device problem was found.There are 8 complaints where the root cause is sporadic failure of one of the component with different issues such as contact problem of the plug/joint, no function of one of the component, loosen screw, short circuit or burned out led.No patient involvement or injuries of personal was reported.There is 1 complaint with a broken component, but the root cause is not comprehensible.There is 1 complaint where the light outlet is polluted / encrusted due to thermal influences.There is i complaint where the lamp has no function due to wear and tear.Richard wolf medical instruments corporation (rwmic) considers this mdr closed.Rwmic will submit a follow up report when new information becomes available.

• Brand Name: ENDOLIGHT
• Type of Device: LIGHT SOURCE LED 2.2 80W
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14416947
• MDR Text Key: 300316338
• Report Number: 9611102-2022-00020
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

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 Model Number: 5164001
• Device Catalogue Number: 5164001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/17/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 09/06/2022
• Supplement Dates FDA Received: 05/20/2022; 09/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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
• Treatment: CAMERA BOX.(INFORMATION REQUESTED).; LOGIC 4K CAMERA CONTROLLER.S/N: (B)(6).