MAUDE Adverse Event Report: RICHARD WOLF GMBH INTRAUTERINE PROBE

Model Number	8378.00
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 june 04, 2019, richard wolf medical instruments corporation (rwmic) received a report from a non-profit organization, (b)(6), 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.".

• Brand Name: INTRAUTERINE PROBE
• Common Device Name: INTRAUTERINE PROBE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 8741135
• Report Number: 1418479-2019-00027
• Device Sequence Number: 19466558
• Product Code: HDC
• UDI-Device Identifier: 04055207040003
• UDI-Public: 04055207040003
• 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: Other Health Care Professional
• Type of Report: Initial
• 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: 8378.00
• Device Catalogue Number: 8378.00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 06/27/2019
• 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