MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PICK, 90°, 1 MM, 16 CM

Model Number 225210

Device Problem Fracture (1260)

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

Event Date 11/23/2023

Event Type  Injury  

Event Description

It was reported that the tip broke off during use.The surgeon could not find the broken tip and it could potentially have remained in the patients ear.No harm to the patient.The procedure could be completed successfully.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

• Brand Name: PICK, 90°, 1 MM, 16 CM
• Type of Device: PICK, 90°
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18661816
• MDR Text Key: 334794563
• Report Number: 2020550-2024-00029
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225210
• Device Catalogue Number: 225210
• Device Lot Number: BF01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2024
• Device Age: 20 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other