MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,OUTER,INSULATED, 5MM. 36CM,; CLICKLINE INSULATED OUTER TUBE

Model Number 33300

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The facility has not provided any additional information or returned the device for evaluation.They did provide a picture of the device with a foreign piece inside a bag next to the sheath, which we suspect was from the distal end of the sheath/tube meant to secure the insert.

Event Description

Allegedly per the customer, during a procedure a metal piece came off from inside the sheath and was removed from the patient.

• Brand Name: TUBE,OUTER,INSULATED, 5MM. 36CM,
• Type of Device: CLICKLINE INSULATED OUTER TUBE
• 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: 10555491
• MDR Text Key: 209223367
• Report Number: 9610617-2020-00106
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 4048551002308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935071
• 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: 09/18/2020

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: 33300
• Device Catalogue Number: 33300
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention