MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ASSEMBLY,MULTIFUNCTIONAL VALVE

Model Number	30103M1
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the piece retrieved from the patient, the customer had no further information to share.The cannula was shipped to the customer approximately 12 years ago.
Event or Problem Description
Allegedly, a patient came in complaining of pain.X-ray revealed a dome portion of a valve door was left inside the patient from a surgery a year ago.The customer suspects it is karl storz washer or plastic dome off the trocar, but cannot confirm.

• Brand Name: ASSEMBLY,MULTIFUNCTIONAL VALVE
• Common Device Name: MULTIFUNCTIONAL VALVE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 8596678
• Report Number: 9610617-2019-00043
• Device Sequence Number: 2074735
• Product Code: GCJ
• UDI-Device Identifier: 04048551117613
• UDI-Public: 4048551117613
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K940347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2019

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: 30103M1
• Device Lot Number: KD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other