MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; HYSTEROSCOPE 30° Ø 3.9MM WL 217MM RIGID

Model Number 8986402

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2019

Event Type  malfunction  

Event Description

It was reported to richard wolf that "when using the scope it became hazy and hard to see thru.This has happened before and the customer would like to know why it keeps happening.No patient injury.Case was completed." additional information from the user facility: "while doing hysteroscopy the lens got hazy and it was hard to see.The picture was not clear however we were able to see enough to finish procedure." 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.

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.Investigation report from richard wolf gmbh: product appearance: used.Complaint condition verified: yes.Repeat repair: no.Met specifications: no.Test method: functional, visual.Equipment used: test according to gmbh test instructions 01-001-8442pa.Probable root cause: other, see conclusion.Physical findings: there is moisture in the optical system, resulting in blurry vision.Furthermore, the light emission end surface is overheated.Conclusion: the cladding tube shows distal mechanical damage to the lens.As a result of these mechanical influences, the cementing on the lens was damaged and leaking.In addition, the light emission end surface is heavily soiled and overheated during use with a high-performance light projector as a result of these cleaning errors.Complaint valid: no - the cause of the error is attributable to the fault of the customer action required: repair.In ga-e200, the user is instructed to perform visual and functional checks after each and before each 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.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.7.2 functional check check the all components for easy assembly.Check all connectors for secure connection.Check the irrigation, drain and insertion stopcocks/ports (10)(11)/(12) for easy operation.Rinse out the irrigation and drain stopcocks (11)/(12) with an irrigator.The dilation medium should form a jet at the distal end.In the case of gas, no pressure should be built up.Check that the stopcock plug (13) is securely engaged in the stopcock housing (14).Check the stopcocks (10/11/12) for tightness.(fig.10) connect a supply tube, turn the stopcock plug (b) to the closed position.Replace the stopcock (b) should the stopcock leak.Check the stopcock plug (13) for easy operation inside the stopcock housing (14).Check compatibility between light connector, flexible light cable and light source.Checking image quality and light output: any deposits on the glass surfaces can cause the field of view to become stained or blurred which may considerably impair light transmission.' clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), wipe difficult-to-remove deposits with instrument cleaner* (fig.11).Also in the if are complete reprocessing instructions/procedure.The user is also asked to refer to ga-j020 which is available through richard wolf.Important! further notes and instructions on reprocessing are described in manual ga-j020 "reprocessing of richard wolf heat-stable instruments" and must be followed.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: PANOVIEW PLUS
• Type of Device: HYSTEROSCOPE 30° Ø 3.9MM WL 217MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14552717
• MDR Text Key: 300790905
• Report Number: 1418479-2019-00045
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8986402
• Device Catalogue Number: 8986402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INFORMATION REQUESTED, NOT GIVEN
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 228 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White