MAUDE Adverse Event Report: UROMEDICA, INC. BLUNT-TIP TROCAR

Model Number	750042
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The perforation was detected via cystoscopy.Light bleeding was observed.Contrast medica appeared on the uromedica u-channel sheath following the perforation.The physician indicated that he dilated with the blunt trocar, and felt resistance build up and then give way.Uromedica complaint#: (b)(4).
Event or Problem Description
Interoperative bladder perforation (patient's left side) during a proact implantation procedure.The bilaterial implantation procedure was completed successfully.Perforation treated with temporary catheterization.

• Brand Name: BLUNT-TIP TROCAR
• Common Device Name: TROCAR
• Manufacturer (Section D): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer (Section G): UROMEDICA, INC.; 1840 berkshire lane north; plymouth MN 55441
• Manufacturer Contact: lisa van ryn ; 1840 berkshire lane north; plymouth, MN 55441
• MDR Report Key: 14756068
• Report Number: 3003477176-2022-00013
• Device Sequence Number: 16477375
• Product Code: EZY
• UDI-Device Identifier: 00180668000137
• UDI-Public: 0100180668000137
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 750042
• Device Lot Number: UM00811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male