MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-06 for HOPKINS TELESCOPE 30?, 4 MM, 30 CM 26105BA manufactured by Karl Storz Se & Co. Kg.
[178095642]
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.
Patient Sequence No: 1, Text Type: N, H10
[178095643]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2020-00017 |
| MDR Report Key | 9679558 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-06-17 |
| Date Mfgr Received | 2019-08-29 |
| Device Manufacturer Date | 2013-06-28 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOPKINS TELESCOPE 30?, 4 MM, 30 CM |
| Generic Name | RIGID HYSTEROSCOPE |
| Product Code | FAJ |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 26105BA |
| Catalog Number | 26105BA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |