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

Model Number	8546
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Insufficient Information (4580)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure on (b)(6) 2023, the device broke and cut the patient.
Additional 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 or Problem 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.
Additional 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).
Additional Manufacturer Narrative
Per evaluation findings by the manufacturing site: most probable root cause: user error.The error description is not comprehensible.It was reported that during a procedure the device broke and cut the patient.The customer returned the 8546 / handle sleeve only for evaluation.For application the 8546 handle sleeve has to be connected to a laryngoscope blade.The 8546 / handle sleeve has no direct contact to the patient and did not show neither any breakages or abnormalities nor sharp edges.Only signs of normal tear and wear were detected.It is assumed that the laryngoscope blade caused the injuries (cut) to the patient due to sharp edges.The used laryngoscope blade was not returned.In the ifu 970000114; version:4.0 - 12/2020, chapter 8.9 it is stated that the operator has to check the medical device above others for damages.Damaged or corroded medical devices must be withdrawn from use.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
Udi : related data quality updates only: the initial mdr had the correct udi number but the first digit "0" was omitted.Please see section d4 of this mdr form for the updated udi number.

• Brand Name: HANDLE SLEEVE
• Common Device Name: 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
• Report Number: 9610617-2023-00379
• Device Sequence Number: 14429461
• Product Code: CCW
• UDI-Device Identifier: 04048551210130
• UDI-Public: 04048551210130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8546
• Device Catalogue Number: 8546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 03/14/2024; 06/10/2024; 07/24/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/19/2023; 04/05/2024; 07/08/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8546LD1/INTERNAL COMPLAINT (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 77 KG