FOREIGN BODY FORCEPS, 28 CM
Received Jun 7, 2023 · Event occurred Apr 10, 2018
Report 9610617-2023-00910 · MDR key 17079694
Device
Generic name
Foreign Body Forceps, 28 Cm
Manufacturer
Karl Storz Se & Co. KgModel number
27071TJCatalog number
27071TJ
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS EVENT WITH A FOREIGN BODY FORCEPS, 28 CM. ACCORDING TO THE INFORMATION RECEIVED, DURING JJ PROBE REMOVAL WITH A SPECIFIC FORCEPS, THIS FORCEPS BROKE. THE PATIENT HAD A WOUND OF URETHRA WITH BLEEDING REQUESTING BLADDER CATHERIZATION FOR 24 HOURS. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Additional Manufacturer Narrative
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. NO PRODUCT WAS RETURNED. THEREFORE, NO PHYSICAL INVESTIGATION CAN BE EXECUTED. THE COMPLAINT RECORDS HAVE BEEN ANALYZED FOR SIMILAR CASES. 149 SIMILAR FAILURE DESCRIPTION IN RELATION TO A CONSUMPTION OF 11.867 UNITS WERE FOUND. THEREOF 3 COMPLAINTS AS POTENTIAL INCIDENTS BUT AFTER EVALUATION NOT REPORTABLE. IN THE VAST MAJORITY OF CASES THE FORCEPS BROKE DUE TO MECHANICAL IMPACT E.G. OVERLOAD CAUSED BY THE OPERATOR. NO INDICATIONS FOR A PRODUCT RELATED ISSUE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).