MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; HYSTEROSCOPE

Model Number	8986402
Medical Device Problem Codes	Optical Problem (3001); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.A follow up will be provided upon receipt of additional information and/or completion of the device evaluation.
Event or Problem Description
On (b)(6) 2019, the user facility reported the following to richard wolf medical instruments corporation (rwmic): when using the scopes, they become hazy and hard to see through.No patient injury, case was completed.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Specifically, was the device being used on a patient when the issue occurred? yes.Was there any injury or illness to patient or other personnel due to issue? no.Did the issue cause a delay in the procedure being performed that put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes how was the patient anesthetized? general.
Event or Problem Description
The purpose of this submission is to report the results of the device investigation, see manufacturers narrative (h10).
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with new information: see section h4 for device manufacture date, section h10 for device investigation results, and h6 for adverse event codes.Investigation report from richard wolf gmbh: product appearance: used, broken; complaint condition verified: yes; repeat repair: yes; met specifications: no; test method: functional, visual; equipment used: test instructions 8986402pa; probable root cause: user handling, other.Physical findings: a.The cover tube is bent.As a result of the bending of the cover tube, the lens and the prisms are broken at this point in the optical system.B.The light emission end surface is discoloured.The discoloration at the light exit surface was caused by overheating through high light energy during long continuous operations.Conclusion: all described causes are not attributable to a product defect or defects in production or repair.The bending of the cover tube due to mechanical overload and its consequences as well as thermal overheating are based on customer fault.Complaint valid: no, customer fault action required: repair.In the ifu, ga-e 200 / usa / 2012-07 v3.0 / eco 2012-0438, the user is reminded the device has limited strength, checks to run through prior to use 6 use caution ! the products have only limited strength ! exerting excessive force will cause damage, impair the function and thus endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Ensure that no missing instrument parts remain in the patient.Do not use products which are damaged, incomplete or have loose parts.6.3.1 light; important ! use only products with type bf applied parts in conjunction with this endoscope.Warning ! accumulation of heat due to high light energy! danger of inadvertent tissue damage due to insufficient distance between the light exit area and the tissue.Do not touch the light exit area and avoid direct contact with the tissue.Warning ! fire hazard! do not place the endoscope onto heat-sensitive, flammable surfaces, such as dark drapes, as the extreme heat generated in the light exit area will lead to inadmissibly high temperatures or even ignition.Lay down the endoscope at a safe place.If you do not use the endoscope for some time, switch off the light source.7 checks: caution! if products are damaged or incomplete.Possible injury of patient, user or third person.Run through the checks before and after each use.Do not use products which are damaged or incomplete or have loose parts.Return damaged products together with loose parts for repair.Do not attempt to do any repairs yourself.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: PANOVIEW PLUS
• Common Device Name: HYSTEROSCOPE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8947566
• Report Number: 1418479-2019-00043
• Device Sequence Number: 2088242
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 05/24/2022
• Report Date (Section F): 08/29/2019

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: Health Professional
• Device Model Number: 8986402
• Device Catalogue Number: 8986402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White
• Date Report Sent to FDA: 08/29/2019