MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 30°, 4 MM, 30 CM; RIGID HYSTEROSCOPE

Model Number	26105BA
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was evaluated by the manufacturer, (b)(4).As per the evaluation: the fiber optics are partially damaged and the optics show corrosion.A reason for the damaged fibers could be hitting or bending of the optics.Corrosion can be caused by incorrect preparation / incorrect drying.A root cause for the described failure could be a longer application, which leads to a heat development [overheating].This can cause burns if the light cable is placed directly on the patient.The ifu points out that a light cable shouldn't lay directly on the patient.The damage of the product is not caused by a production problem or material defect.
Event or Problem Description
As per a vigilance report received from the factory in (b)(4), a patient received a burn on the inner aspect of the left thigh thought to have occurred by the end of the hysteroscope coming into contact with the patient's leg when the power was on.The lesion was roughly the same size as the hysteroscope tip (4 - 5mm).Accessing the endometrial cavity was difficult and the operators were switching between using the hysteroscope to facilitate dilatation, and hegar dilators.When the hysteroscope was not being actively used, it was placed on the patient's abdomen.The consultant would usually ask a member of the nursing team in theatre to turn the power off when the hysteroscope is not being actively used, but in this case, possibly because there was continual switching between means of dilating the cervix, this does not seem to have been the case.Once the injury was identified, the medical and nursing teams inspected the drapes but found no evidence of charring or burning.Patient assessed at the burns clinic the following day.The burn was found to be full thickness, and the patient went to surgery there for excision and primary closure of the lesion.She was discharged the following day.

• Brand Name: HOPKINS TELESCOPE 30°, 4 MM, 30 CM
• Common Device Name: RIGID HYSTEROSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 9679558
• Report Number: 9610617-2020-00017
• Device Sequence Number: 16936683
• Product Code: FAJ
• UDI-Device Identifier: 04048551093597
• UDI-Public: 4048551093597
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K943176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 26105BA
• Device Catalogue Number: 26105BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention