3.5MM 90ÿ° SERFAS ENERGY PROBE
Report
- Report Number
- 0002936485-2014-00436
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Date of Event
- June 4, 2014
- Report Date
- June 4, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- GEI
- PMA / PMN Number
- K071859
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
THE TIP BREAKING (CERAMIC) CONDITION WAS CONFIRMED ON THE RETURNED UNIT. THE DETACHED CERAMIC PORTION WAS RETURNED. THE BROKEN AND DETACHED PIECE WAS PLACED BACK IN PLACE TO VERIFY THAT THERE WAS NO MISSING PORTION. THE BROKEN PIECE FIT RIGHT IN PLACE. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON-CONFORMING COMPONENT: ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. BASED ON THE FACT THAT NO NONCONFORMANCE REPORTS RELATED TO NON-CONFORMING COMPONENT OR SIMILAR COMPLAINTS HAVE BEING IDENTIFIED FOR THE REPORTED LOT NUMBER THAT COULD BE RELATED TO THE REPORTED CONDITION, IT CAN BE RULED OUT AS A POSSIBLE ROOT CAUSE. POOR ASSEMBLY PROCESS: A 30X INSPECTION OF THE PROBE'S TIP ASSEMBLY IS PERFORMED ON ALL THE PROBES DURING MANUFACTURING. ACCORDING TO THE ACTIVATION HISTORY THE UNIT WAS ACTIVATED 31 TIMES (NOT INCLUDING THE FIRST FIVE ACTIVATIONS), FOR 79 SECONDS, FOR CUTTING TISSUE AT A CUT POWER LEVEL SETTING OF 5 AND 7 (POWER SETTING RANGE IS 0-7) WHICH INDICATES THAT THE UNIT WAS ASSEMBLED PROPERLY AND WAS FULLY OPERATIONAL FOR AN EXTENDED PERIOD OF TIME, BEFORE THE CONDITION WAS OBSERVED. THEREFORE, A POSSIBLE WORKMANSHIP (ASSEMBLY) RELATED CONDITION IS A LESS LIKELY POSSIBLE CONTRIBUTOR BASED ON THE LINE CONTROLS AND DEVICE HISTORY RECORD REVIEW AND RETURNED UNIT'S ACTIVATION HISTORY REVIEW. MISUSE: THE PROBE IS DELIVERED INSIDE A BLISTER IN WHICH THE UNIT IS SNAPPED IN PLACE, AND THE BLISTER IS PLACED INSIDE A BOX, WHICH PROVIDES PROTECTION TO THE TIP OF THE PROBE. IN THE EVENT THAT THE PROBE IS DELIVERED TO THE CUSTOMER WITH A DAMAGED TIP, THEN THE UNIT MUST BE DISCARDED BEFORE USE. THE RETURNED UNIT SHOWED NO EVIDENT SIGNS THAT IT COULD HAVE BEEN USED FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, AS A PRYING OR SCRUBBING TOOL, AND THAT EXCESSIVE FORCE WAS USED DURING SURGERY, WHICH CAN RESULT IN THE DAMAGE OBSERVED AND WHICH IS CONTRAINDICATED AS PER USER INSTRUCTIONS FOR THE SERFAS ENERGY PROBES FAMILY (P/N 1000-400-763). EVEN THOUGH A POSSIBLE IMPACT BY ANOTHER INSTRUMENT (CUTTER, BUR, ETC) OR A HEAVY OBJECT WHILE SITTING ON THE MAYO STAND OR WHILE BEING INSERTED INTO THE PATIENT'S SHOULDER CANNOT BE COMPLETELY RULED OUT THIS POSSIBLE CONTRIBUTOR IS LESS LIKELY TO BE THE ROOT CAUSE FOR THE REPORTED CONDITION. ACCORDING TO THE INFORMATION INITIALLY PROVIDED IT WAS BELIEVED THAT THE SHAVER MIGHT HAVE HIT THE PROBE CAUSING THE BREAKAGE. HOWEVER, IT WAS LATER CONFIRMED BY THE STRYKER REPRESENTATIVE THAT THE SHAVER WAS USED AFTER THE BREAKAGE WAS OBSERVED. IT WAS REPORTED THAT THE CUTTER WAS USED TO SUCTION THE BROKEN OFF PROBE INSULATION TIP THEREFORE THIS POSSIBLE CONTRIBUTOR WAS RULED OUT. A POSSIBLE NON-CONFORMING COMPONENT CANNOT BE RULED OUT AS A POSSIBLE CONTRIBUTOR. IN SUM, THE UNIT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.
IT WAS REPORTED THAT A PIECE OF THE UNIT BROKE OFF AND WAS RETRIEVED.
IT WAS REPORTED THAT A PIECE OF THE UNIT BROKE OFF AND WAS RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378240 | 3.5MM 90ÿ° SERFAS ENERGY PROBE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | STRYKER ENDOSCOPY-SAN JOSE | 14048AE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |