MAUDE Adverse Event Report: RICHARD WOLF GERMANY (GMBH) CAMERA HEAD 3CCD HDTV AOTOCLAVE

Model Number 85550912

Device Problems Device Operates Differently Than Expected (2913); Optical Distortion (3000)

Patient Problem Laceration(s) (1946)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Richard wolf ((b)(4)) investigation/evaluation currently in process.(b)(4) considers this report open, follow-up report to be submitted once investigation is complete.(b)(4).

Event Description

During videothoracoscopic lobectomy, after 1 hour of use, it was not possible to distinguish the anatomic structures.Despite the replacement of fiber light cables and scopes, as it was not possible to safely continue the surgical procedure, it was necessary to carry out a thoracotomy, thus remarkably increasing the trauma to the patient.The procedure was completed through a thoracotomy increase of post-op pain, surgical scare larger (15 cm) than the usual 3 small thoracoscopic accesses.

Manufacturer Narrative

Richard wolf (b)(4) performed endurance testing over a 12 day period.No error occurred during endurance testing.(b)(4) considers this report closed, a follow-up report to be submitted if any additional information received.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of richard wolf (b)(4)(manufacturer).

• Brand Name: CAMERA HEAD 3CCD HDTV AOTOCLAVE
• Type of Device: CAMERA HEAD
• Manufacturer (Section D): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GERMANY (GMBH); registration #9611102; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: dawn clark ; 353 corportate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 6239197
• MDR Text Key: 64930644
• Report Number: 9611102-2016-00020
• Device Sequence Number: 1
• Product Code: FWF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

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 Operator: Physician
• Device Model Number: 85550912
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2011
• 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 CONTROLLER
• Patient Age: 60 YR