MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS OPTIK 30°; RIGID HYSTEROSCOPE

Model Number 26008BA

Device Problem Optical Problem (3001)

Patient Problem Discomfort (2330)

Event Date 05/21/2021

Event Type  malfunction  

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 inspection, rod lens breakage due to mechanical impact was observed.In addition, the optic was repaired by unauthorised personnel because the gravring has an incorrect position, the serial number is not marked according to karl storz labelling specifications and the connection between the shaft and the optic head is glued instead of welded.The root cause is most likely due to mechanical overload i.E user error.Risk level and probability are still adequate.The event is filed under internal karl storz complaint id ((b)(4)).

Event Description

It was reported that there was event with a hopkins optik.According to the information received, the hysteroscope was checked prior to use and no issues identified.After inserting scope into womb consultant felt picture was too dark, he felt it was caused by light cable.Light cable changed but consultant felt view had not improved so scope changed.Consultant felt that picture was better and proceeded to insert scope into womb for a second time.Patient reassured during the whole process.Towards the end patient began to feel lightheaded.Head of couch was laid flat and scope removed as the procedure had been completed.Patients observation checked and within normal range and lightheaded had feeling resolved.Patient then stated that she felt the issue with light source and scope had made the procedure more uncomfortable and had contributed to her feeling unwell.

• Brand Name: HOPKINS OPTIK 30°
• Type of Device: RIGID HYSTEROSCOPE
• 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: 16950094
• MDR Text Key: 315494830
• Report Number: 9610617-2023-00629
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/17/2023

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: 26008BA
• Device Catalogue Number: 26008BA
• Device Lot Number: 1005BR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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