MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TELESCOPE,HOPKINS II, 0º, ENLARGED VIEW; RIGID ENDOSCOPE

Model Number	26046AA
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by our on-site specialist: customer had a case on (b)(6) 2020 using items above; a burn mark was found on patient after surgery.All items have been tested and were in good condition.Per the customer, the case was a laparoscopic salpingo-oophorectomy.Area on the left side of patients abdomen was noted to appear as "pink with skin sloughed off".There was no damage or burn mark on the drapes and there was no post-op treatment of the "pink marking", only observation.
Additional Manufacturer Narrative
Per the evaluation findings of the telescope: chipped lens-visible debris, scratches on eyepiece, and scratched shaft.The most likely cause of the burn on patient's abdomen is the telescope with an active light cable attached was laid on the patient.When using the light cable with an attachment and laying it on the patient, the light can become occluded at the distal end, resulting in transfer of light to heat.In this case, it is most likely the coupler on the light cable attached to the telescope that got hot and resulted in the burn.Our ifu cautions against laying active instruments on patients without turning the light source to standby.

• Brand Name: TELESCOPE,HOPKINS II, 0º, ENLARGED VIEW
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14338216
• Report Number: 9610617-2022-00066
• Device Sequence Number: 17692224
• Product Code: GCJ
• UDI-Device Identifier: 04048551092088
• UDI-Public: 4048551092088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K935279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: 26046AA
• Device Catalogue Number: 26046AA
• Device Lot Number: 121C3L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Female