MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE

Model Number 27292AMA

Device Problem Optical Problem (3001)

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

Event Type  malfunction  

Event Description

It was reported that there was event with a optic.According to the information received, at (b)(6) hospital on (b)(6) 2020, the prostate dropped into the bladder was nucleated, so this telescope was connected to the camera, but could not be used due to blurred vision.Therefore, surgery was discontinued.This was the first use.The following day, another telescope was replaced, and the operation was performed again, and the procedure was completed.We have confirmed that it is obvious that the airtightness of the product is lost.In addition, since the damage inside the objective lens was confirmed, it is suspected that the product's airtightness was lost due to damage to this part.However, no traces of load (indentations, scratches, etc.) that could cause damage to the objective lens were identified.The customer recognizes the event as an incident and requests a report on the cause.Please describe the cause of this event in detail." "the surgery was discontinued.The following day, another telescope was replaced, and the operation was performed again, and the procedure was completed.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.During the investigation of the product, it was found that when focusing through the rod lens system, a possible slight rod lens breakage was detected.The cover glass is soldered in at a slight angle, but it is tight, no bubble was found under the cover glass.Under ambient conditions no failure can be found, a clear image is visible.But after a heat treatment, the image is very poor/cloudy.Based on the investigation, it is concluded that the most probable root cause for the poor image/ blurred vision is that during the assembly of the optics, moisture was trapped inside and due to heat, the moisture condensed on the optical system.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: HOPKINS TELESCOPE
• Type of Device: HOPKINS 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: 16950065
• MDR Text Key: 315458782
• Report Number: 9610617-2023-00626
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27292AMA
• Device Catalogue Number: 27292AMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2021
• 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
• Patient Outcome(s): Required Intervention