PIVOT GUARDIAN, FRAME
Received Jun 30, 2022 · Event occurred Jun 21, 2022
Report 0002936485-2022-00405 · MDR key 14879258
Device
Generic name
Apparatus, Traction, Non-powered
Manufacturer
Stryker Endoscopy-san JoseModel number
3105000100Catalog number
3105000100
Product problems
- Device Contamination with Chemical or Other Material
- Material Fragmentation
- Device Contamination with Chemical or Other Material
Patient
Unknown
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
- Foreign Body In Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT THE SALES REPRESENTATIVE GOT SLIVERS OF THE DEVICE IN THEIR FINGER WHILE WIPING IT DOWN WHICH REQUIRED INTERVENTION TO REMOVE.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: FOREIGN SILVER MATERIAL ON USER FINGERS PROBABLE ROOT CAUSE: DESIGN: SHARP EDGES ALONG DEVICE, MATERIAL CRACKS CREATING SHARP EDGES (01D), SHARP EDGES ON VELCRO. PROCESS: SHARP EDGES NOT REMOVED DURING FINISHING OPERATIONS. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE SALES REPRESENTATIVE GOT SLIVERS OF THE DEVICE IN THEIR FINGER WHILE WIPING IT DOWN WHICH REQUIRED INTERVENTION TO REMOVE.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: FOREIGN SILVER MATERIAL ON USER FINGERS PROBABLE ROOT CAUSE: DESIGN: * POOR MATERIAL SELECTION. (EASILY SCRATCHED, DENTED, CHIPPED). (EASILY TORN, FRAYED, ETC). * IMPROPER PACKAGING DESIGN. PROCESS: * INSUFFICIENT CLEANING PROCESS OR ABRASIVE CLEANING. * IMPROPER FINISHING PROCESS. * IMPROPER SCREEN PRINTING. * IMPROPER HANDLING IN MGF. * USE OF WRONG PACKAGING COMPONENTS. APPLICATION: * POOR HANDLING DURING SHIPPING. * SUBASSEMBLIES ARE DROPPED AND DAMAGED DURING ASSEMBLY/DISASSEMBLY FOR SERVICE. * EXPOSURE TO AIR/SURROUNDING ENVIRONMENT LEADS TO FOAM DISCOLORATION. ¿ USE ERRORS. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE SALES REPRESENTATIVE GOT SLIVERS OF THE DEVICE IN THEIR FINGER WHILE WIPING IT DOWN WHICH REQUIRED INTERVENTION TO REMOVE.