MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HANDLE SLEEVE; RIGID LARYNGOSCOPE HANDLE SLEEVE

Model Number 8546

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).

Event Description

It was reported that during a procedure on nov-10-2023, the device broke and cut the patient.

• Brand Name: HANDLE SLEEVE
• Type of Device: RIGID LARYNGOSCOPE HANDLE SLEEVE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 18271380
• MDR Text Key: 329775502
• Report Number: 2020550-2023-00379
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2023,12/05/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8546
• Device Catalogue Number: 8546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other