NGAGE NITINOL STONE EXTRACTOR
Report
- Report Number
- 1820334-2023-00912
- Event Type
- Malfunction
- Date Received
- July 18, 2023
- Report Date
- September 28, 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, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY: A REPRESENTATIVE OF GZO SPITAL WETZIKON INFORMED COOK ON 04JUL2023 OF AN INCIDENT INVOLVING NGAGE NITINOL STONE EXTRACTORS (RPN: NGE-022115) FROM LOT #15204976. IT WAS REPORTED THAT THE 3-4 DEVICES WOULD NOT OPEN AND CLOSE PROPERLY DURING A URETEROSCOPY PROCEDURE. NO ADDITIONAL PROCEDURES WERE REPORTED. NO FURTHER INFORMATION WAS AVAILABLE. REPORT REFERENCE NUMBER (B)(4) WAS ALSO OPENED IN RESPONSE TO THIS COMPLAINT. INVESTIGATION ¿ EVALUATION A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, OF THE DEVICE WERE CONDUCTED. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED A LIKELY RELATED NON-CONFORMANCE FOR ¿BASKET/GRASPER WILL NOT OPEN/CLOSE¿ IN WHICH 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 DATABASE SEARCH DID IDENTIFY TWO COMPLAINTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_SHEF_REV1; THE IFU DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. THE ISSUE HAS BEEN IDENTIFIED AS BEING WITH THE BASKET ASSEMBLY, WHICH IS A SUPPLIED COMPONENT. A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) AND CAPA (CORRECTIVE AND PREVENTATIVE ACTION) WERE CREATED TO ADDRESS THE ISSUE. THE CAUSE FOR THE ISSUE HAS NOT YET BEEN DETERMINED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, NO FURTHER ACTION IS REQUIRED. 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.
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.
E1: (B)(6). E3: CUSTOMER OCCUPATION: UNKNOWN. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS RECEIVED ON 19JUL2023 STATING THAT IT WAS POSSIBLE FOR THE 'NGAGE NITINOL STONE EXTRACTOR TO OPEN BEFORE AND AFTER IT WAS IN THE "URS" AND WAS NOT POSSIBLE TO OPEN DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NOT ANY SECTION OF THE DEVICE REMAINING IN THE PATIENT'S BODY, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE.
AS REPORTED, THE 'NGAGE NITINOL STONE EXTRACTOR' IS UNABLE TO OPEN AND CLOSE AS INTENDED AND IT IS "DIFFICULT TO STEER". ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 840700 | NGAGE NITINOL STONE EXTRACTOR | FFL DISLODGER, STONE, BASKET, URETERAL, METAL | FFL | COOK INC | 15204976 | 10827002482972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |