MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOCAM; LOGIC 4K CAMERA HEAD

Model Number	85525942
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rw (b)(4) reports "the device was received on 03/02/2022 with the note 'camera unit failed multiple times during procedure'.The user questionnaire regarding a potential incident was sent on 03/03/2022 and it was received on 03/07/2022.According to the user questionnaire, the user facility has already contacted rw(b)(4) prior on 02/25/2022." the investigation is ongoing.A follow-up report will be submitted as soon as the investigation is completed.
Event or Problem Description
It was reported to richard wolf (b)(4) that "the user has reported that the image flickered and failed completely during the procedure with the use of the erbe device.There was a delay of 30 minutes, the procedure could be completed with another camera cable.".
Event or Problem Description
The purpose of this submission is to report the results of the device investigation completed by the manufacturer.See manufacturers narrative (h10).
Additional Manufacturer Narrative
Rw gmbh reports "the device was received on 03/02/2022 with the note 'camera unit failed multiple times during procedure'.The user questionnaire regarding a potential incident was sent on 03/03/2022 and it was received on 03/07/2022.According to the user questionnaire, the user facility has already contacted rwgmbh prior on 02/25/2022.Update: g1, g9, h2, h3, h10 corrected: catalog number in d4.During the current investigation in the assigned department, it was determined on the camera head 85525942 that the camera cable 72325394 has a loose contact and the anti-kink sleeve of the camera plug is torn.The cause of the reported issue is due to mechanical influence such as kink damage, which has damaged the cable in the camera plug's anti-kink sleeve area, resulting in image failure.The logic 4k camera head 85525942 with the serial number (b)(6) was produced on 03/09/2020.According to the prodiction plan, there were no deviations.The logic 4k camera head was delivered to the user facility on 05/28/2020.Taking into account all the findings determined, no systematic defects can be derived either in terms of functionality or from a design and manufacturing perspective.The use is informed and advised in the related ifu bb-a282-05 / en / us / v2.0 / 2021-07 / pk21-0089 about the product combination as well as about visual and functional checks: 6 combinations caution be careful not to combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.- the products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc.Are the same.- also follow the instruction manuals of the products used in conjunction with this product.8 checks caution injury due to damaged or incomplete products! injuries of the patient, user and others are possible.- run through the checks before and after each use.- do not use the products if they are damaged or incomplete or have loose parts.- return damaged products together with any loose parts for repair.- do not attempt do to any repairs yourself.8.1 visual check attention - before assembling the endoscope and objective lens, check that the glass surfaces on the endoscope, objec-tive lens and camera head are dry and dust-free.- any soiling can be removed with a cotton swab soaked with alcohol (wooden or plastic swab carrier, not met-al).1.Check the camera head and the accessories before and after each use for damage, sharp edges, loose or missing parts and rough surfaces.2.Check the connection cables and adapters for damage.3.Any inscription, lettering or labeling necessary for the safe intended use must be legible.-> any inscription, lettering or labeling leading to handling or reprocessing errors must be reinstated.4.Fogging or functional impairment may indicate the ingress of liquid.8.2 functional check preconditions for carrying out the function check are a technically perfect state and the correct setup of the devices.This must also be guaranteed within the scope of the visual check.1.Carry out the function check of the camera head together with the camera controllers of the endocam logic hd camera controller 552510x und endocam logic 4k camera controller 5525301 series in accordance with instructions for use ga-a282.-> after connecting the camera head, an interference-free live image must appear on the monitor.2.If the live image is poor (e.G.Black, interference or color bars): disconnect the camera head and reconnect after 3 seconds.3.If there still is no interference-free live image: restart the camera controller.Possible hazard were considere in the risk assessment e2-2: camera heads, document version v00001 with the corresponding extent of damage and probability of occurrence and assessed with an acceptable risk.This assessment is still valid even taking into account the current case.Richard wolf gmbh considers this matter closed.However, in the event rw gmbh receives any additional in-formation a follow-up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting the report on behalf of rw gmbh.

• Brand Name: ENDOCAM
• Common Device Name: LOGIC 4K CAMERA HEAD
• 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: zsofia bartholome-nagy ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 13827566
• Report Number: 9611102-2022-00010
• Device Sequence Number: 11849272
• Product Code: FET
• UDI-Device Identifier: 04055207063163
• UDI-Public: 04055207063163
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 85525942
• Device Catalogue Number: 85525942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown