InjuryBSP
SPROTTE® STANDARD
Received Apr 29, 2026 · Event occurred Feb 27, 2026
Report 9611612-2026-00007 · MDR key 25027068
Device
Generic name
Sprotte® Standard
Manufacturer
Pajunk Gmbh MedizintechnologieCatalog number
331151-31B
Lot number
1571
Product problems
- Break
Patient
92 YR · Male
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THIS INCIDENT TOOK PLACE IN GERMANY. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.
Description of Event or Problem
(B)(4). INCIDENT OCCURRED IN GERMANY. TENTITIVE TRANSLATION AND SUMMARY: INTRODUCER BROKE DURING PROCEDURE. ONE PART OF THE BROKEN INTRODUCER COULD BE REMOVED, THE OTHER PART REMAINED IN THE PATIENT. PHYSICIAN DECIDED TO NOT REMOVE THE PART REMAINING IN PATIENT.