MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE

Model Number	8650.415
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Caution! increased risk potential if the image is blurred! danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Check the image quality of the endoscope before use (section 8.2).8.2 function check: check image quality and light output in conjunction with the system components.Check the glass surfaces for any deposits.Deposits on the glass surfaces can cause a spotted or blurred field of view and hence impair light transmission considerably.Clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic) and hard-to-remove deposits with a suitable instrument cleaner.Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Warning! intense heat due to high light energy! danger of inadvertent tissue damage 'due to insufficient distance between the light exit area and the tissue 'due to soiling/contamination in the light exit area 'if high performance sources are used do not touch the light exit area and avoid direct contact with the tissue.Remove any soiling.Caution! be careful if products are damaged or incomplete! 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, incomplete or have loose parts.Return damaged products together with any loose parts for repair.Do not attempt to do any repairs yourself.Should additional information become available, a follow up report will be submitted.
Event or Problem Description
On july 11, 2019, a customer requested five (5) scopes be returned to richard wolf medical instruments corporation (rwmic) for repair.The customer reported that a substance was being cooked at the end and requested to know what the substance was.The devices were returned to rwmic on july 16, 2019.Upon return, photographs were taken of the scopes.Photographs showed was appeared to be blood and tissue cooked on 4 out of 5 of the scope's distal tips.A visual and functional evaluation was conducted for telescope part # 8650.415, serial # (b)(4).As the device had already been cleaned prior to leaving the receiving department, no residue could be detected.The housing was found to be bent and dented and one (1) of the lens was found to be broken.Additionally, the eyepiece and color ring were third party parts, customer confirmed the device had been repaired by a third party.Probable root cause was determined to be user error/misuse and/or user handling; the device may have been exposed to some kind of physical force and/or the damage may have due to the third party repair.On july 14, 2019, the customer provided the following additional information: what kind of procedures were being performed with these devices? - cystoscope cases do you have any evidence of a functional test prior to using these instruments? (see ifu ga-s001 section 8.2) - only function.Before placing in pan to be sterilized, spd personnel look through the scope, surgical techs in the or do not conduct any type of check.How were devices cleaned, what solutions were used? - unknown how the devices are cleaned in spd, but from the or, the techs place a wet towel over the scopes to help keep them wet.When are the issues noticed? the problem is noticed when spd is unable to see clearly through the scope or the surgeon is unable to see anything.Who reported the problem? either spd will report or the or room will report can more detail regarding the circumstances under which they encountered the issue be provided? no more than what i have.Mentioned above.As there were five (5) impacted scopes, five (5) mdrs will be submitted: 1418479-2019-00034 (part # 8654.422 / serial # (b)(4)); 1418479-2019-00035 (part # 8650.415 / serial # (b)(4)); (part # 8650.415 / serial # (b)(4)); 1418479-2019-00037 (part # 8650.415 / serial # (b)(4)); 1418479-2019-00038 (part # 8654.422 / serial # (b)(4)).It is unknown if the scopes were being improperly cleaned/sterilized, resulting in a buildup of tissue, prior to them being used in the or.It is unknown how long the tissue may have been building up for, nor is it known how many cases the devices may have been used in; therefore, the event date is unknown.

• Brand Name: PANOVIEW
• Common Device Name: TELESCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9050517
• Report Number: 1418479-2019-00036
• Device Sequence Number: 1891626
• Product Code: GCM
• UDI-Device Identifier: 04055207018354
• UDI-Public: 04055207018354
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K993103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019
• Report Date (Section F): 09/13/2019

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: No Information
• Device Model Number: 8650.415
• Device Catalogue Number: 8650.415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2019
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 09/13/2019