MAUDE Adverse Event Report: RICHARD WOLF GMBH FUSION DESIGN; 2.5 MM LIGHT CABLE

Model Number	80662530
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the product history evaluation has been completed and/or new information becomes available.
Event or Problem Description
It was reported by the user facility: "light source end of the 80662530 light cable was removed from the 5142002 light source, and was set on the paper drape covering the patient.The heat of the metal connector on the light cable caused a burn to the patient." additional details: will the device be returned? no.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? yes.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? no.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? yes.
Event or Problem Description
The purpose of this submission is to report the results of the product history evaluation.The user facility did not return the device.Within the last three years (> 10/01/2018) richard wolf gmbh received only one complaint with this product.During the same time more than 3.600 pieces have been sold worldwide.The complaint was due to a warranty investigation from a german customer and was received in june 2021.The light cable showed only normal signs of use.All tests and the light transmission were according our specifications.According to our experience due to high energy of the light source, the adapter and glass surfaces on the fiber light cable or the endoscope are extremely hot when disconnected from the light source.This may cause burns if inadvertently the patient, user or others touch the parts.To avoid such burns the user is advised in the instruction manual ga-a-287 (or ga-a264 for 5142002) with several warnings about the intense heat due to high light energy.The fire hazard and danger of burns.When placing the endoscope onto heat-sensitive flammable surfaces (dark drapes, etc.) the high light energy at the light exit area of the endoscope can cause high temperatures or even ignition.As the existing data does not show any signs of systematic errors or errors regarding the manufacturing and the important information is available for the users in the ifu no further action required.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and/or changed information.Rwmic considers this mdr open.Rwmic will submit a follow up report should the user facility respond to our queries and provide additional information.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility was contacted three times in an effort to collect patient information and user information.The sales rep was contacted and asked to make contact with the user facility.He responded ((b)(6) 2021) that his contact was going to complete the questionnaire but so far we've received nothing, as of (b)(6) 2021, rwmic has not received a response.Rwmic considers this mdr closed.If we receive additional information from the user facility or sales rep, a report will be submitted.
Event or Problem Description
The purpose of this submission is to close this mdr.

• Brand Name: FUSION DESIGN
• Common Device Name: 2.5 MM LIGHT CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12561276
• Report Number: 1418479-2021-00045
• Device Sequence Number: 16530693
• Product Code: GCT
• UDI-Device Identifier: 04055207026328
• UDI-Public: 04055207026328
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2021

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
• Operator of Device: No Information
• Device Model Number: 80662530
• Device Catalogue Number: 80662530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 10/28/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/08/2021; 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 300 WATT XENON LIGHT SOURCE5142002; 300 WATT XENON LIGHT SOURCE5142002
• Outcome Attributed to Adverse Event: Other