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

Model Number 8986402

Device Problems Optical Problem (3001); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2019

Event Type  malfunction  

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 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.

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 complaint condition verified: no, the scope didn't become hazy repeat repair: yes met specifications: no test method: functional, visual equipment used: test instructions 8986402pa probable root cause: user handling physical findings: the outer tube is a little bent.There are a few particals in the scope but they are not visual-effective.The scope has no leakage.Conclusion: there was an overload on the outer tube caused by a customer fault.Complaint valid: no, mechanical overload was found but no moisture in the scope 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.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.

Event Description

The purpose of this submission is to report the results of the device investigation, see manufacturers narrative (h10).

• Brand Name: PANOVIEW PLUS
• Type of Device: 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: 8947567
• MDR Text Key: 168446010
• Report Number: 1418479-2019-00042
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04055207023686
• UDI-Public: 04055207023686
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019,05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: 07/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2019
• Distributor Facility Aware Date: 07/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White