MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 8986.401

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  No Answer Provided  

Event Description

There was a two inch metal object in the hysteroscope that was observed when lap grasper was placed through the hysteroscope port.Patient under anesthesia, lying on or table for surgery.Patient had sterile hysteroscope inserted into cervix by md.Upon almost fully placing lap grasper through hysteroscope port, a 2-inch metal rod was partially pushed out of the other end of the port towards the patient.Before the metal rod was fully pushed out of hysteroscope, the hysteroscope was pulled out of the cervix carefully and the metal rod was pulled out of hysteroscope once out of patient to prevent injury.Management team notified of event.Spd management will be notified of event.We are reaching out to repair company to find out if the metal rod is apart of the inner sheath of the scope.Will circle back to close the loop today.Spd (sterile processing department) manager was able to provide clarification that the hysteroscope in question has been cleaned, washed, reprocessed and successfully as well as passed our steam sterilization parameters.Next steps: we are working to obtain the scope and rod.We will need to send the instrumentation and rod out to either wolf to determine whether or not the rod is apart of the inner sheath.All stake holders are unfamiliar with this specific piece, whether it is from spd, apart of the scope, or on the clinic end.Scope and rod are in route to spd.This is all the information we have available.

• Brand Name: PANOVIEW PLUS
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 11285015
• MDR Text Key: 230482143
• Report Number: 11285015
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

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?: No
• Device Operator: No Information
• Device Model Number: 8986.401
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10950 DA