FDA Adverse Event
Injury
Summary report: N
TENDON STRIPPER, 7 MM
MDR report key: 16113335
·
Received January 6, 2023
Report
- Report Number
- 2020550-2023-10006
- Event Type
- Injury
- Date Received
- January 6, 2023
- Report Date
- January 6, 2023
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- LXH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. INTERNAL KARL STORZ REFERENCE NUMBER: (B)(4). KARL STORZ SE & CO. KG WAS INFORMED THAT THIS DEVICE WAS USED FOR A FURTHER SURGERY. THIS CASE WILL BE HANDLED/REPORTED AS CASE (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE TENDON STRIPPER BECAME WORN AFTER APPROX. 50 USES. THIS WORN INSTRUMENT WAS USED FOR SURGERY, THAT TORE 2 TENDONS. THERE WAS A PROLONGATION OF APPROX. 1H AND A SECOND SURGEON WAS NEEDED. NO FURTHER INFORMATION REGARDING THE STATE OF HEALTH IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573393 | TENDON STRIPPER, 7 MM | TENDON STRIPPER | LXH | KARL STORZ SE & CO. KG | 28729AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |