CONSTELLATION Surgical Procedure Pack

Description of Event or Problem

A physician reported that water leaked when using the trocar during surgery. The procedure type was unknown. The surgery was completed on the same day after replacing the product with a new one. There was no patient impact.

Additional Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental MDR will be filed as necessary in accordance with 21 CFR 803.56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).