MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. PORTIO CONE ATTACHMENT

Model Number	8378.90M
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	04/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.
Event or Problem Description
On (b)(6) 2019, richard wolf medical instruments corporation (rwmic) received a report from a non-profit organization, (b)(6) institute, regarding a user facility that had experienced an issue with the uterine manipulator.It was reported that a day after a procedure, it was found that the acorn tip had been retained inside the patient.Upon following up with the user facility the following additional information was provided: "patient was brought to the operating room for laparotomy for ectopic pregnancy.The surgeon used a cohen uterine manipulator device.After surgery was completed the surgeon removed the cohen device and placed it on the back table.Counts were done but cohen device was not counted since it came in peel pack.The patient was taken to the unit, the following morning the patient went to use the bathroom to void and that's when the acorn tip from the cohen device had dropped in the toilet.The ob surgeon on duty at the time, examine the patient and took x-rays to make sure no other retained items.Exam and x-ray were clear and no harm to the patient.".
Additional Manufacturer Narrative
Section d4 is no longer applicable as the product was manufactured prior to 2016.Section f is no longer applicable as it was determined that richard wolf medical instruments corp.Is the legal manufacturer.A follow up will be submitted upon completion of the complaint investigation and/or upon receipt of new additional information.
Event or Problem Description
Follow up 1 to provide corrected and additional information.

• Brand Name: PORTIO CONE ATTACHMENT
• Common Device Name: PORTIO CONE ATTACHMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 8741136
• Report Number: 1418479-2019-00026
• Device Sequence Number: 2523282
• Product Code: HHI
• UDI-Device Identifier: 04055207040010
• UDI-Public: 04055207040010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019
• Report Date (Section F): 06/27/2019

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: 8378.90M
• Device Catalogue Number: 8378.90M
• Device Lot Number: 51004313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Date Report Sent to FDA: 06/27/2019