MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE,CUTTING,STERILE.24FR; MONOPOLAR SINGLE USE CUTTING LOOP

Model Number 27050G-S

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned.Therefore no evaluation was performed.

Event Description

Allegedly per the customer, during a turp the doctor noticed at the end of the procedure that the loop broke in half and per the surgeon nothing fell inside the patient, and with no ill effects to the patient.The procedure was completed.

• Brand Name: ELECTRODE,CUTTING,STERILE.24FR
• Type of Device: MONOPOLAR SINGLE USE CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 10872506
• MDR Text Key: 230671407
• Report Number: 9610617-2020-00127
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551394540
• UDI-Public: 4048551394540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 27050G-S
• Device Catalogue Number: 27050G-S
• Device Lot Number: 37CJ2543
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74