MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 27040XA

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2019

Event Type  malfunction  

Event Description

Ceramic sheath on resectoscope broke in half before using on a patient.The tip of the resectoscope sheath has broken off.This particular sheath was checked by the registered nurse/or tech in the room.There was no issue noted.Prior to use at the field, the doctor checked the tip again and the tip crumbled into a couple of pieces.All pieces have been collected along with the sheath.There was no harm to the patient as the tip was check prior to use.

• Brand Name: N.A.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8508592
• MDR Text Key: 141767010
• Report Number: 8508592
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040XA
• Device Lot Number: UR03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA