MAUDE Adverse Event Report: RICHARD WOLF GMBH LOGIC HD CAMERA HEAD CABLE

Model Number	85525922
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Optical Problem (3001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) considers this case open.The manufacture and user facility will be contacted to collect missing information.A follow up report will be submitted upon receipt of new or additional information.
Event or Problem Description
On (b)(6) 2019, the user facility reported the following to (b)(4): having an issue with pictures being automatically taken and the brightness increasing automatically.This was the second time it happened.Both times it happened after they unplugged and plugged the camera back in to the endocam to re-white balance.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general.
Event or Problem Description
Follow up report to provide new and/or changed information.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new and changed information.Richard wolf medical instruments corporation (rwmic) considers this case open.Upon device evaluation or any additional information a follow up report will be submitted to the fda.
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.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #2 is to provide fda with new/missing information: results of the device investigation (h10), adverse event codes (h6) related to the device investigation.According to the device investigation report: complaint investigation is based on the assessment of the available information from the repair performance on 2/11/2019.No evaluation was performed based on repair order confirmation at the time of receipt indicated that the item should be scrapped.Product was not originally received as a complaint.Product disposition: scrap rw considers this case closed.Should additional information become available a follow up report will be submitted.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation.See manufacturers narrative (h10).

• Brand Name: LOGIC HD CAMERA HEAD CABLE
• Common Device Name: LOGIC HD CAMERA HEAD CABLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8382937
• Report Number: 1418479-2019-00007
• Device Sequence Number: 1650474
• Product Code: FET
• UDI-Device Identifier: 04055207027387
• UDI-Public: 04055207027387
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022
• Report Date (Section F): 04/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 85525922
• Device Catalogue Number: 85525922
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/30/2019
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/01/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/03/2019; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 04/03/2019