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 Problems Laceration(s) (1946); Insufficient Information (4580)

Event Date 11/10/2023

Event Type  Injury  

Event Description

It was reported that during a procedure on (b)(6) 2023, the device broke and cut the patient.

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

Per new information provided by the customer, the device was used for intubation on a male patient (76.7 kg, 52 years old) on nov-10-2023.The device broke during the intubation and cut the patient's lip.Instant care was provided to the patient right after this happened.There is no lasting impact on the patient according to the customer.They completed the procedure with a back-up unit, with a delay of about five minutes.

Manufacturer Narrative

Additional information is provided in section d10.On march-14-2024, we were made aware of the battery insert (item # 8546ld1) was also used in the same case as a concomitant item.The event is filed under internal karl storz complaint id (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 18271377
• MDR Text Key: 329776599
• Report Number: 9610617-2023-00379
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551210130
• UDI-Public: 4048551210130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/19/2023; 03/14/2024
• Supplement Dates FDA Received: 12/19/2023; 04/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: 8546LD1/INTERNAL COMPLAINT (B)(4).
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG