BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
Report
- Report Number
- 1018233-2024-04706
- Event Type
- Malfunction
- Date Received
- August 6, 2024
- Date of Event
- July 12, 2024
- Report Date
- November 13, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FFL
- UDI-DI
- 00801741111518
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. RECEIVED (4) PHOTO SAMPLES. THE FIRST PHOTO SAMPLE SHOWS THE OVERVIEW OF THE SKYLITE STONE BASKET. THE SECOND PHOTO SHOWS THE SIDEVIEW OF THE SKYLITE STONE BASKET HANDLE. THE THIRD PHOTO SHOWS THE BOTTOM OF THE SKYLITE STONE BASKET HANDLE. THE FOURTH PHOTO SHOWS THE SKYLITE STONE BASKET. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), SKYLITE STONE BASKET. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THE STONE BASKET REMAINS OPEN AND DOES NOT CLOSE DESPITE PUSHING HANDLE LEVER IN BOTH DIRECTIONS. NO ACTIONS TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿INTENDED USE: SKYLITE TIPLESS NITINOL STONE BASKETS ARE INTENDED FOR USE THROUGH THE WORKING CHANNEL OF A RIGID OR FLEXIBLE URETEROSCOPE DURING THE ENDOSCOPIC REMOVAL OF RENAL AND URETERAL STONES. IT IS INTENDED FOR PATIENTS UNDERGOING URETEROSCOPIC PROCEDURES. WARNINGS: SOME OBJECTS MAY BE TOO LARGE TO BE REMOVED ENDOSCOPICALLY USING A RETRIEVAL DEVICE. THE USE OF FLUOROSCOPY AND/OR X-RAY TO DETERMINE THE SIZE OF THE OBJECT IS RECOMMENDED. DO NOT USE THE SKYLITE TIPLESS NITINOL STONE BASKET IF THE OBJECT IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY, AS IT MAY RESULT IN PATIENT INJURY AND PAIN. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR MAY LEAD TO INJURY, ILLNESS OR DEATH OF A PATIENT. DO NOT ATTEMPT TO REPAIR, REASSEMBLE, OR ALTER THE DEVICE IN ANY WAY. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. USERS AND/OR PATIENTS WITHIN THE EUROPEAN UNION, SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. USERS OUTSIDE OF THE EUROPEAN UNION SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE REGULATORY AUTHORITY OF THE COUNTRY IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. PRECAUTIONS: BEFORE USING, INSPECT FOR ANY BREACH OF PACKAGING TO ENSURE STERILITY OF PRODUCT. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. 1.9 FR AND 2.4 FR STONE BASKETS: FOR USE WITH A URETEROSCOPE HAVING A 3.4 FR. WORKING CHANNEL OR AS DETERMINED BY PHYSICIAN. 3.0 FR STONE BASKETS: FOR USE WITH A URETEROSCOPE HAVING A 3.6 FR. WORKING CHANNEL OR AS DETERMINED BY PHYSICIAN. DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENTS OR LASER. KINKS IN THE SHEATH WILL HINDER THE MECHANICAL OPERATION OF THE BASKET, MAY AFFECT INSERTION OR WITHDRAWAL OF THE BASKET AND HAS THE POTENTIAL TO DAMAGE THE ENDOSCOPE¿S INSTRUMENT CHANNEL. DO NOT ALLOW THE DEVICE TO BE DIRECTLY FIRED UPON BY ANY LITHOTRIPSY DEVICES. TO DO SO MAY RESULT IN DAMAGE TO THE DEVICE AND COULD RESULT IN PATIENT INJURY. POTENTIAL COMPLICATIONS THAT MAY RESULT FROM THE USE OF A BASKET IN AN ENDOSCOPIC UROLOGICAL PROCEDURE INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION; EVULSION; EDEMA; ENTRAPMENT; LACERATION; BASKET INVERSION; HEMORRHAGE; INABILITY TO DISENGAGE FROM IRRETRIEVABLE OBJECT. CAUTIONS: OBJECTS THAT ARE TOO LARGE TO BE REMOVED THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACT. IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE.¿ UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT WIRE OF THE SKYLITE STONE BASKET DID NOT MOVE WHEN WIRE WAS OPENED OR CLOSED BY STEERING WHEEL OPERATION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 25JULY2024, CUSTOMER CONFIRMED THAT NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT WIRE OF THE SKYLITE STONE BASKET DID NOT MOVE WHEN WIRE WAS OPENED OR CLOSED BY STEERING WHEEL OPERATION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 25JULY2024, CUSTOMER CONFIRMED THAT NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1662169 | BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET | SKYLITE STONE BASKET | FFL | C.R. BARD, INC. (COVINGTON) -1018233 | NGHZ4012 | 00801741111518 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |