MAUDE Adverse Event Report: RICHARD WOLF GMBH; PORTIO CONE ATTACHMENT SZ LARGE

Model Number	837891
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).(b)(4) is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information becomes available.
Event or Problem Description
Rwmic received medwatch report mw5098196 on 01/19/2021: portio cone attachment inadvertently detached from uterine manipulator.This has occurred on 2 separate occasions.It was not noticed the first occurrence and remained in the patient.Fda safety report id# (b)(4) on 01/22/2021: spoke to customer who stated that this is an ongoing issue with the cones being loose on the handles.Patient went home with the cone inside and expelled it.Will the device be returned? yes.Was the device being used during a procedure when the 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? no.Did the delay put the patient at risk? (only applicable if there was a report of delay) n/a.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

• Common Device Name: PORTIO CONE ATTACHMENT SZ LARGE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11240176
• Report Number: 1418479-2021-00001
• Device Sequence Number: 17159185
• Product Code: HDC
• UDI-Device Identifier: 04055207040027
• UDI-Public: 04055207040027
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 837891
• Device Catalogue Number: 8378.91
• Device Lot Number: 51013717
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1