N-COMPASS NITINOL STONE EXTRACTOR
Report
- Report Number
- 1820334-2022-00522
- Event Type
- Malfunction
- Date Received
- April 1, 2022
- Date of Event
- January 26, 2022
- Report Date
- November 30, 2022
- Manufacturer
- COOK INC
- Product Code
- LQR
- UDI-DI
- 10827002362502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PMA/510(K) #: K173009. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
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. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: (B)(6) (CHINA) INFORMED COOK ON 17MAR2022 OF AN ISSUE WITH AN N-COMPASS NITINOL STONE EXTRACTOR (RPN: C-NTSE-2.4-115-NC3; LOT: 14162929). ON 26JAN2022, DURING REMOVAL FROM THE PACKAGE, IT WAS NOTED THE BASKET COULD NOT BE ADVANCED. NO PATIENT CONTACT WAS MADE WITH DEVICE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND 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 14162929 AND NC3-024115-BNS COMPONENT LOT NS13976479 DID NOT HAVE ANY NONCONFORMANCES OR ADDITIONAL COMPLAINTS. NC3-024115-BNS COMPONENT LOT NS14004238 REVEALED ONE RELATED NONCONFORMANCE FOR BASKET SHAPE INCORRECT. THIS STEP IS CHECKED 100% PER QC. ALL NONCONFORMING DEVICES WERE SCRAPPED PRIOR TO FURTHER PRODUCTION. BASKET LOT NS13976479 WAS USED IN 2 ADDITIONAL FINAL LOTS 14162930 AND 14299633 IN WHICH THERE WERE NO RELATED NONCONFORMANCES OR ADDITIONAL COMPLAINTS. BASKET LOT NS14004238 WAS USED IN 1 ADDITIONAL FINAL LOT 14162928 IN WHICH THERE WERE NO RELATED NONCONFORMANCES OR ADDITIONAL COMPLAINTS. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_NCNSE_REV1] ¿NCOMPASS NITINOL STONE EXTRACTORS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK COULD NOT ESTABLISH A CAUSE FOR THIS EVENT. THERE IS NO EVIDENCE OF MANUFACTURING DEFICIENCY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5 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. 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.
IT WAS REPORTED AN N-COMPASS NITINOL STONE EXTRACTOR COULD NOT BE ADVANCED PRIOR TO USE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
ADDITIONAL INFORMATION PROVIDED 05MAY2022 STATED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER, SIMILAR DEVICE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2022 INDICATING THAT THE ISSUE WAS DETECTED ONCE IT WAS REMOVED FROM THE PACKAGE AND THE DEVICE DID NOT HAVE CONTACT WITH THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2492267 | N-COMPASS NITINOL STONE EXTRACTOR | LQR DISLODGER, STONE BILIARY | LQR | COOK INC | N/A | 14162929 | 10827002362502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |