MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS RIGID LAPAROSCOPE; 0 DEGREE,4MM,18CM

Model Number	7230AA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is on-going.Product has been returned for evaluation.Photographs of telescope show gouging around distal end, with chipped rod lens.Discoloration around light fibers on light taper.No signs of temperature defect.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).
Event or Problem Description
It was reported that an event with the 7230aa hopkins telescope 0 degree, 4mm.According to the information received, while using the scope on a patient, the scope overheated injuring the patient.Patient suffered what appeared to be thermal burn 1st degree.Per the facility the scope was used during the entire surgical procedure, approximately 5 hours.The patient suffered what appeared to be a thermal burn 1st degree.
Additional Manufacturer Narrative
Per manufacture evaluation: the ifu warns the risk of injury the highly concentrated light energy can cause the distal end, the light port, adjacent componets and tissue in front of the light emission window to heat up this can cause burns to the patient, user and surgical accessories.During the examination of the optic in our possession, we were able to detect leakage of the rod lens system due to a chemically attacked solder seam.The chemical attack of the distal solder seam caused leakage, resulting in moisture penetration into the rod lens system.Furthermore, various mechanical damages in the form of scratches, impact marks and mechanical material removal can be observed in the distal area.The aforementioned damage is due to clinical use and not to a production defect.Furthermore, the aforementioned damages are not causally responsible for the resulting burn of the patient.In connection with this case, there is a 495nac light cable used in combination (zc 200963353 mdr23-125 972992) which, according to the customer, will not be returned because this cable was disposed of by the user.For this reason, a more detailed investigation and root cause analysis cannot be performed.A possible cause for the strong heating of the optics and the resulting burning of the patient may be the use of an unbranded light source, a light output that is set too high, or soiling of the light connection on the optics side.Furthermore, a too small distance to the surrounding tissue can cause a burn.The event is filed under internal karl storz complaint id (b)(4).
Event or Problem Description
It was reported that an event with the 7230aa hopkins telescope 0 degree, 4mm.According to the information received, while using the scope on a patient, the scope overheated injuring the patient.Patient suffered what appeared to be thermal burn 1st degree.Per the facility the scope was used during the entire surgical procedure, approximately 5 hours.The patient suffered what appeared to be a thermal burn 1st degree.

• Brand Name: HOPKINS RIGID LAPAROSCOPE
• Common Device Name: 0 DEGREE,4MM,18CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17135777
• Report Number: 9610617-2023-00124
• Device Sequence Number: 3941298
• Product Code: EOB
• UDI-Device Identifier: 04048551193822
• UDI-Public: 4048551193822
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K945788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: 7230AA
• Device Catalogue Number: 7230AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 495NA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 65 KG