MAUDE Adverse Event Report: KARL STORTZ KARL STORTZ 26 FRENCH RESECTOSCOPE SHEATH

Model Number 27040XA

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

During the surgical procedure transurethral resection of the prostate a piece of the resectoscope broke off inside the patient.

• Brand Name: KARL STORTZ 26 FRENCH RESECTOSCOPE SHEATH
• Type of Device: 26 FRENCH RESECTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORTZ; aliso viejo CA 92656
• MDR Report Key: 6830385
• MDR Text Key: 84135541
• Report Number: MW5071831
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

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
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: XW02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 93