NGAGE NITINOL STONE EXTRACTOR
Report
- Report Number
- 1820334-2023-00974
- Event Type
- Malfunction
- Date Received
- July 28, 2023
- Date of Event
- July 9, 2023
- Report Date
- October 23, 2023
- Manufacturer
- COOK INC
- Product Code
- FFL
- UDI-DI
- 10827002482972
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: POSTAL CODE: (B)(6) E3: OCCUPATION = (B)(6) / GZO / RESPONSIBLE OR G4: PMA/510(K) NUMBER = EXEMPT THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EVENT DESCRIPTION: AS REPORTED, DURING A URETEROSCOPY AND REMOVAL OF STONE FRAGMENTATIONS IN THE KIDNEY, THE BASKET FROM AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN DURING THE PROCEDURE WHEN INSERTED IN THE SCOPE. THE DEVICE COULD BE OPENED BEFORE IT WAS INSERTED INTO THE SCOPE AND AFTER IT WAS REMOVED FROM THE SCOPE. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WERE CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF, COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED IN AN OPENED PACKAGE. THE BASKET WAS CLOSED AND COULD NOT BE OPENED. ONE OF THE BASKET WIRES WAS BROKEN. THERE WAS A BEND IN THE BASKET SHEATH AND THE SUPPORT SHEATH. NEITHER BEND APPEARED SIGNIFICANT ENOUGH TO BE THE CAUSE OF THE FAILURE OF THE BASKET TO OPEN. IT IS LIKELY THE DAMAGE TO THE BASKET SHEATH, SUPPORT SHEATH AND THE BROKEN WIRE OCCURRED DURING RETURN OF THE DEVICE WITHOUT ITS SHIPPING TRAY. A REVIEW OF THE DEVICE HISTORY RECORD FOUND A NON-CONFORMANCE FOR BASKET/GRASPER WILL NOT OPEN/CLOSE THAT WAS LIKELY RELATED TO THE COMPLAINT ISSUE WHERE TWO DEVICES WERE SCRAPPED. ALL DEVICES IN THE LOT WERE TESTED FOR PROPER FUNCTIONING DURING MANUFACTURING AND AT SUBSEQUENT QUALITY CONTROL CHECKS. ALL DEVICES THAT PASSED THE INSPECTIONS AND WERE NOT SCRAPPED WERE FOUND TO BE WITHIN SPECIFICATIONS. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS ONE OTHER RELATED COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WAS CONDUCTED. ALL EXTRACTORS ARE VERIFIED TO ASSURE THE BASKET OPENS AND CLOSES PROPERLY. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND QUALITY CONTROL DOCUMENTS DOES NOT PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION OR TO SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE ARE NONCONFORMING. THE INSTRUCTIONS FOR USE (IFU), DOES NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT COULD NOT BE OPENED. DAMAGE WAS NOTED TO THE BASKET SHEATH, SUPPORT SHEATH, AND BASKET WIRE, BUT IT WAS LIKELY THE DAMAGE OCCURRED DURING RETURN OF THE DEVICE WITHOUT THE SHIPPING TRAY AND WAS NOT RELATED TO INABILITY OF THE BASKET TO FUNCTION. A SUPPLIER CORRECTIVE ACTION REQUEST AND A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WERE CREATED TO ADDRESS THE ISSUE. A FIELD ACTION ASSESSMENT WAS PERFORMED AND IT WAS DETERMINED THAT NO FIELD ACTION WAS NECESSARY. THE CAUSE FOR THE ISSUE HAS NOT YET BEEN DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
AS REPORTED, DURING A URETEROSCOPY AND REMOVAL STONE FRAGMENTATIONS IN THE KIDNEY, THE BASKET FROM AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN DURING THE PROCEDURE WHEN INSERTED IN THE SCOPE. THE DEVICE COULD BE OPENED BEFORE IT WAS INSERTED INTO THE SCOPE AND AFTER IT WAS REMOVED FROM THE SCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
ADDITIONAL INFORMATION WAS RECEIVED 26SEP2023: ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320765 | NGAGE NITINOL STONE EXTRACTOR | FFL DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | COOK INC | 15204976 | 10827002482972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |