MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MINIATURE TELESCOPE 0°, 1.2 MM, 20 CM

Model Number R27033AA

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The previous reportability decision for this event was reversed based on a retrospective review.The complaint reported broken fibers and it was black and spotty.The technical evaluation confirmed multiple broken fibers in the image bundle.A possible manufacturer's defect was reported.It was further reported that should detailed results of the evaluation be provided at a later date, the complaint will be re-opened to include this information.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that there were issues with 27033aa / r27033aa (miniature straight forward telescope).The complaint describes a darkened image / black spot.

• Brand Name: MINIATURE TELESCOPE 0°, 1.2 MM, 20 CM
• Type of Device: MINIATURE TELESCOPE
• 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: 17980612
• MDR Text Key: 326203123
• Report Number: 9610617-2023-00306
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2023

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: R27033AA
• Device Catalogue Number: R27033AA
• Device Lot Number: 4082382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 10/20/2023
• 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