MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 20° Ø 9.3MM SL 177MM RIGID

Model Number	892109205
Medical Device Problem Codes	Leak/Splash (1354); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf medical instruments corporation is the importer of this device.Rwmic is submitting this report on behalf of richard wolf gmbh (manufacturer).Rwgmbh considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
Rwmic reference complaint no: (b)(4).On september 16, 2022, it was reported to richard wolf medical instruments corp.(rwmic) by a user facility representative regarding product id#: 892109205, sn: (b)(4)."this newly received repair exchange scope leaks irrigation around the forward seal." additional information reported by the user facility representative: (email, dated september 20, 2022).This issue was discovered in the operating room.The scope was leaking irrigation fluid from the rear seal at all pressure levels, such that the set irrigation pressure could not be maintained even with excessive flow.This resulted in poor surgical visibility and consumption of 36 liters of irrigation on a case that would normally take 12-15 liters.The case was completed and there was no patient injury as a result." complaint data collection questionnaire repair customer service: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? yes.Additional informations provided by user facility representative: (form 5206 (03), rwmic med watch questionnaire).What was the procedure: spinal stenosis laminotomy.Purpose of procedure: treatment.Additional informations provided by user facility representative: (email, dated september 20, 2022).1.The case was extended by approximately one hour.2.Surgery continued, but visibility was partially impaired due to the inability to adequately clear the surgical field with proper pressure irrigation.3.No additional treatment was required.4.The ultimate outcome was not affected, just prolonged.The case was successfully completed.Rwmic mdr awareness date: 16-sept-2022.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new information regarding device investigation results of this mdr.According to the investigation report: (rwgmbh investigation report device evaluation, form 5020 (12), dated: 12/08/2022).According to the findings, the inner sheath is scratched and there is a slightly corrosion at the distal end.There is debris in the optical system which is visible as shadow in the image.The user is advised in the relevant ifu ga-b 251 /usa/ 2012-08 v 1.0 / eco 2012-0561 in section 7.3.3 image quality about potential risk of the image is blurred as well as to check the image quality of the device before use.Furthermore, there are instructions in section 8 checks for visual and function check to perform before and after each use.According to the findings, the probable root cause is user error/ reprocessing error.Product disposition: the device is recommended for repair.
Event or Problem Description
Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device investigation.

• Brand Name: PANOVIEW PLUS HD
• Common Device Name: DISCOSCOPE 20° Ø 9.3MM SL 177MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: pforzheimer strasse 32; d-75438 knittlingen, germany
• MDR Report Key: 15540108
• Report Number: 9611102-2022-00053
• Device Sequence Number: 5997007
• Product Code: HRX
• UDI-Device Identifier: 04055207035115
• UDI-Public: 04055207035115
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K000046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 892109205
• Device Catalogue Number: 892109205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White