MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR

Model Number	10101JA
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a case on (b)(6) 2024, the spring connector piece on the prismatic light deflector came apart and the 3 components had to be retrieved from the patient.No patient injury was reported.However it prolonged the case and they had to do an x-ray check on the patient to confirm they have retrieved all of the broken pieces from the patient.
Additional Manufacturer Narrative
Correction: this incident was deemed as "adverse event" due to the fact that an x-ray had to be taken to ensure that the patient did not have any pieces left inside the body, and a prolongation of the procedure.However, we previously submitted this medwatch only as "produt problem".We therefore will submit this correction now retrospectively.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Changes made from the initial report: ---updated the udi number in section d4.---updated section d9 to yes, and entered the device returned date to the manufacturer.Per investigation by the manufacturing site: our examination of the prism headlight sent in revealed that the installed threaded pin (figure # 6) was broken off and remnants of it were still stuck in the headlight housing (figure # 5).A possible cause may be mechanical damage caused by damage that occurred during one of the applications or by damage during clinical reprocessing, which was ultimately not noticed / determined during the product check before further clinical use and led to the complete breakage of the threaded pin.The components screw for detent, the compression spring, and the detent (see figure # 6) were not available for examination.The evaluation for the requested period from (b)(6) 2020 - (b)(6) 2024 resulted in (b)(4) complaint with a total sales quantity of (b)(4) units and a resulting rate of (b)(4).The damage is not attributable to a production defect due to the fracture pattern of the fragment remaining in the housing.No further action will be taken.This event is filed under internal complaint id (b)(4).

• Brand Name: PRISMATIC LIGHT DEFLECTOR
• Common Device Name: PRISMATIC LIGHT DEFLECTOR
• 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 ; 4242188247
• MDR Report Key: 19388153
• Report Number: 9610617-2024-00146
• Device Sequence Number: 14457967
• Product Code: EOQ
• UDI-Device Identifier: 04048551045268
• UDI-Public: 04048551045268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943700
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

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: 10101JA
• Device Catalogue Number: 10101JA
• Device Lot Number: WZ02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 07/19/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/19/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown