MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RHINO-LARYNGO-FIBERSCOPE 3.5 MM, 30 CM

Model Number 11101RP2

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.The rhino-laryngo-fiberscope 3.5 mm, 30 cm shows massive bite marks in the articulation area.This has damaged the bonding of the proximal fixation thread on the distal rubber - presumably mainly when the endoscope was retracted during biting.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a rhino-laryngo-fiberscope 3.5 mm, 30 cm.According to the information received a thick nylon thread is coming out of the unit (at 3.7 cm from the tip).This can cause damage to the patient.Patient harm is not known at date of this report.Additional patient information is not available.

• Brand Name: RHINO-LARYNGO-FIBERSCOPE 3.5 MM, 30 CM
• Type of Device: RHINO-LARYNGO-FIBERSCOPE 3.5 MM, 30 CM
• 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: 16950071
• MDR Text Key: 315438112
• Report Number: 9610617-2023-00609
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11101RP2
• Device Catalogue Number: 11101RP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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
• Patient Outcome(s): Other