MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW. MORCESCOPE 12° 24.5FR WL 199MM RIGID; MORESCOPE

Model Number	8970402
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/14/2021, the user facility reported the following complaint description: unable to see clearly through the scope.This was the first time it was used since it arrived in october due to other parts of the tray being unavailable.Was the device being used on a patient when the reported issue occurred? yes was there any injury or illness to 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 bac-up device available for use? no was the scheduled procedure completed? yes additional questions to user facility/represenative on 12/16/2021: how long was the delay? the procedure took approximately an extra 45 minutes due to extremely poor visibility.What actions were being done during the delay? when we could identify clearly tissue it was morcellated.We also waited for their other scope to be reprocessed and brought into the room.Did the patient require any additional treatment during the delay or will require another procedure as the result of the delay? no additional treatment nor any additional procedures are indicated at this time.What was the patient's outcome? once the 2nd scope was ready to use, he was able to morcellate the remaining tissue and confirm that no further intervention is indicated.Richard wolf provided an rma number for device return.An investigation is pending device return.
Additional Manufacturer Narrative
Rwmic considers this mdr open, rwmic will submit a follow up report after the device is evaluated and/or if new information becomes available.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation/evaluation: the device was received by richard wolf medical instrument and evaluated using visual and functional means.The reported condition, unable to see clearly through scope, was not confirmed.According to the technician, "reported problem not justified, scope pass all tests".Probable root cause: no device problem found.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: we've attempted contacting the user facility was contacted twice in an effort to collect patient information and user information.As of 01/11/2022, rwmic has not received a response.New information: the following fields have new information: b3, b5, g6, h2, h6, h10.Changed information: the following fields have changed information: d2,d9, h3, h8.Device labeling was reviewed for patient code and device codes, see below: - patient code: not applicable, no patient problem was reported.- device code: not applicable, no device issue found.Rwmic considers this mdr closed.Should richard wolf receive new information, a follow-up report will be sent to fda as required.

• Brand Name: PANOVIEW. MORCESCOPE 12° 24.5FR WL 199MM RIGID
• Common Device Name: MORESCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strabe32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer str. 32; knittlingen,, baden-wurtemberg 75438 ; GM 75438
• Manufacturer Contact: phillipp schmidt ; pforzheimer str. 32; knittlingen,, baden-wurtemberg 75438 ; GM 75438
• MDR Report Key: 13088282
• Report Number: 1418479-2021-00059
• Device Sequence Number: 5926058
• Product Code: FJL
• UDI-Device Identifier: 04055207023525
• UDI-Public: 04055207023525
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 8970402
• Device Catalogue Number: 8970402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown