FDA Adverse Event Injury Summary report: N

ASM,HEAD,IMAGE 1 S, 4U

MDR report key: 18210185 · Received November 27, 2023

Report

Report Number: 9610617-2021-00026
Event Type: Injury
Date Received: November 27, 2023
Report Date: November 22, 2023
Manufacturer: KARL STORZ SE & CO. KG
Product Code: FET
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 6. THIS PATIENT INCIDENT WAS REPORTED TWICE USING THE FOLLOWING MDR NUMBERS: 961889: 2027009-2021-00023. 961892: 2027009-2021-00026. HOWEVER, THE MANUFACTURING SITE NUMBER "2027009" STATED IN THESE MDRS WAS WRONG. THE CORRECT MANUFACTURING SITE NUMBER IS "9610617". THEREFORE, THE NUMBER HAS BEEN CHANGED IN THIS MEDWATCH AND THIS REPORT HAD TO BE SUBMITTED AS "INITIAL". THE PATIENT INCIDENT WILL BE PROCEEDED UNDER MDR 9610617-2021-00023. THIS MDR 9610617-2021-00026 WON´T BE PROCEEDED ANY INFORMATION CAN BE FOUND WITH REFERENCE NUMBER: 9610617-2021-00023.

Description of Event or Problem · 0

THIS PATIENT INCIDENT WAS REPORTED TWICE USING THE FOLLOWING MDR NUMBERS: 961889: 2027009-2021-00023. 961892: 2027009-2021-00026. HOWEVER, THE MANUFACTURING SITE NUMBER "2027009" STATED IN THESE MDRS WAS WRONG. THE CORRECT MANUFACTURING SITE NUMBER IS "9610617". THEREFORE, THE NUMBER HAS BEEN CHANGED IN THIS MEDWATCH AND THIS REPORT HAD TO BE SUBMITTED AS "INITIAL". THE PATIENT INCIDENT WILL BE PROCEEDED UNDER MDR 9610617-2021-00023. THIS MDR 9610617-2021-00026 WON´T BE PROCEEDED ANY INFORMATION CAN BE FOUND WITH REFERENCE NUMBER: 9610617-2021-00023.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1239425	ASM,HEAD,IMAGE 1 S, 4U	ENDOSCOPE VIDEO CAMERA	FET	KARL STORZ SE & CO. KG

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown