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

Model Number 8378.90M

Device Problem Misconnection (1399)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 04/20/2019

Event Type  malfunction  

Manufacturer Narrative

Rwmic considers this case open.The user facility and manufacturer will be contacted again in an effort to collect missing information.

Event 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.".

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Section d4 is no longer applicable as the product was manufactured prior to 2016.Section f is no longer applicable as it was determined that richard wolf medical instruments corp.Is the legal manufacturer.A follow up will be submitted upon completion of the complaint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 Description

Follow up 1 to provide corrected and additional information.

• Brand Name: PORTIO CONE ATTACHMENT
• Type of Device: PORTIO CONE ATTACHMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 8741136
• MDR Text Key: 202961283
• Report Number: 1418479-2019-00026
• Device Sequence Number: 1
• Product Code: HHI
• UDI-Device Identifier: 04055207040010
• UDI-Public: 04055207040010
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2019,06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 06/27/2019
• Distributor Facility Aware Date: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR