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 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The item is a single use device and therefore not returned by the customer for evaluation.

Event Description

Allegedly per the customer, during a turp the doctor noticed a piece of the wire from the loop arched and fell off in the patient.The doctor removed the broken piece by "flushing the fragment out" per the nurse, with no ill effects to the patient.The electrode was replaced and the procedure 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: 9285317
• MDR Text Key: 165268995
• Report Number: 9610617-2019-00101
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551394540
• UDI-Public: 4048551394540
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• 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: 37A13118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 68