MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL

Model Number 8575KA

Device Problem Sharp Edges (4013)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  malfunction  

Event Description

It was reported that a staff member was injured (minor cut to hand) during cleaning of the instrument laryngoscope holder, göttingen model.No patient involved.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.After completely disassembling and fully examining the provided instrument, no defects could be found on the product.There is no sharp edge and pointed defect which may cause injury during cleaning as reported.Therefore, this issue could not be confirmed.No indication for a material or manufacturing related issue was found during the investigation.The event is filed under internal karl storz complaint id (b)(4).Additional information regarding h6 - component code 4755: part or component not specified.

• Brand Name: LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL
• Type of Device: LARYNGOSCOPE HOLDER, GÖTTINGEN MODEL
• 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
• MDR Report Key: 16950074
• MDR Text Key: 315463699
• Report Number: 9610617-2023-00601
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 8575KA
• Device Catalogue Number: 8575KA
• Device Lot Number: NP04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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