MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE 30° Ø 2.7MM SL 310MM RIGID

Model Number 8974.402

Device Problems Crack (1135); Fracture (1260)

Patient Problems Hemorrhage/Bleeding (1888); Discomfort (2330); Intraoperative Pain (2662)

Event Date 07/27/2022

Event Type  Injury  

Event Description

Rwmic reference complaint no.(b)(4).On (b)(6) 2022, it was reported to richard wolf medical instruments corp.(rwmic) by a sales representative/rwmic that the reported device has "cracked lens." initial information reported by the user facility representative: (richard wolf medical instruments, repair return authorization no.200422956, dated (b)(6) 2022) "scope was inserted in patient when hair "like" crack noticed on lens.Patient's procedure took longer.Patient did experience more discomfort but was not injured." updated information received: (email, (b)(6) 2022).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.On 09-aug- 2022, additional details were provided by the initial reporter (repair return authorization no.200422956) stating "the procedure was supposed to start at 8am.The procedure was delayed until 9:30am.We cleaned the scope, took it apart, checked the camera, cleaned w/ alcohol pad, reassembled, and then had the physician look at it.It look as though there was a hair in the scope.The physician had to change the speculum three time s to try to see around the area in the scope.The patient did not tolerate this well and had additional pain and bleeding.She was kept an additional thirty minutes before she could leave due to pain.I think she was scheduled for hysteroscopy in the surgi-center.There was lengthy delay in care for our other patients as well since a thirty-minute procedure ended up taking two hours.Rwmic mdr awareness date: 09-aug-2022.Also, the purpose of this submission is to provide the results of the device investigation.

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).Device investigation results: rwmic investigation report device evaluation, form 5020 (12) the device was tested visually and functionally.The reported condition was not confirmed and the device also did not meet specifications.The evaluation found the visual inspection of the lens did not find a crack in the lens.If there was a crack in the lens, there would be no image.There was debris found in the optical system that could give an image of a line.This type of damage could have been caused by the scope being dropped.Probable root cause: due to reprocessing additional information's for device labeling included.Ifu ga-s001 / en-us / 2017-03 v3.0 / eco 2016-0136: section 8 - checks 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.Visual check: check the endoscopes in particular in the distal area and the accessories for: damage ,sharp edges ,loose or missing parts , and rough surfaces.Any inscriptions or identification necessary for the safe intended use must be legible.To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated.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.Reprocessing procedure: important! if used as intended and following the manufacturer's instruction manual, it is not necessary to limit the number of possible reprocessing cycles.Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products.Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle.It is the user's responsibility to make sure that the reprocessing process including the resources, material and personnel, is suited to yield the required results.The national and international requirements regarding the validation of the reprocessing process established by the user must be observed.Rwmic considers this mdr closed.Rwmic will submit a follow up report when new information becomes available.

• Brand Name: PANOVIEW
• Type of Device: TELESCOPE 30° Ø 2.7MM SL 310MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15296429
• MDR Text Key: 298663675
• Report Number: 1418479-2022-00023
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04055207023600
• UDI-Public: 04055207023600
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/24/2022,08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8974.402
• Device Catalogue Number: 8974.402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Distributor Facility Aware Date: 07/27/2022
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American