MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOCAM LOGIC HD CAMERA HEAD CABLE 3M; ENDOSCOPE VIDEO CAMERA

Model Number	85525922
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user has reported the following information (translated from french): 43-year-old patient benefiting from an exploratory laparoscopy following a stab wound.During the intervention, the team notices a loss of image from the camera.They have changed the entire video column (incompatible camera from one column to another) impacting the organization and management of the patient (increase in operating time).Risk of conversion from open surgery.Extension of operating time 20 minutes.They have changed the device and could have completed the procedure.Additional information from the manufacturer: the patient had a stab wound, so they were checking if a tissue repair is needed.The user facility did not reported that they had to repair any tissue due to the failure of the camera head or the patient was injuried by the failure.Their only concern was the 20-minute-delay in the procedure.
Additional Manufacturer Narrative
The logic hd camera head cable 3m 85525922, serial number (b)(4) has been inspected in the technical department in accordance with the inspection instruction pa01-001-8957.The prism of the camera head is broken, resulting in glass fragments visible in the camera head.In addition, there is a pinch point on cable of the camera head.Due to the damage to the prism (glass breakage), the cause can be traced back to mechanical influences, such as a knock or a fall of the camera head by the user.Since it is a plastic housing, a permanent deformation does not necessarily have to be present.From our experience, the damage described above can also occur without external deformation of the camera head as a result of a fall or a knock, as well as when the camera head with the c-mount lens screwed on falls to the ground.The c-mount lens was not returned for inspection.The cause of the pinch point on the cable of the camera head is due to a mechanical overload.Based on the investigations and the duration of use at the customer, a manufacturing defect or product problem can be ruled out.The logic hd camera head cable 3m 85525922, serial number (b)(4) was produced on 18 october 2013 and it was delivered to the customer on 25 october 2016.After a repair service.No further repairs were recorded, the last maintenance service was on 2 december 2021.The user is advised in the ifu bb-a282-03 / en / us / v3.0 / 2021-07 / pk17-8970: 2 general safety instructions and guidance for use.The camera cable has only limited strength.Applying excessive force or high mechanical loads can cause damage to the camera cable or wiring resulting in image interference or image failure.Do not pinch, squeeze or excessively bend the camera cable.Do not pull on the camera cable.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 metal).Check the camera head and the accessories before and after each use for damage, sharp edges, loose or missing parts and rough surfaces.Check the connection cables and adapters for damage.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.Fogging or functional impairment may indicate the ingress of liquid.In the risk assessment e2-2 camera head, document version: v00001, production-related, handling and design hazards with regard to a functional impairment as well as risks from a product that cannot be used were consid-ered with the corresponding extent of damage and the assumed probability of occurrence and evaluated with an acceptable risk.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) is submitting the report on behalf of rw gmbh.

• Brand Name: ENDOCAM LOGIC HD CAMERA HEAD CABLE 3M
• Common Device Name: ENDOSCOPE VIDEO CAMERA
• 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: 13995124
• Report Number: 9611102-2022-00014
• Device Sequence Number: 17437838
• Product Code: FET
• UDI-Device Identifier: 04055207027387
• UDI-Public: 04055207027387
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 85525922
• Device Catalogue Number: 85525922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2013
• 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 Age: 43 YR
• Patient Sex: Unknown