N-COMPASS NITINOL STONE EXTRACTOR
Report
- Report Number
- 1820334-2025-00029
- Event Type
- Injury
- Date Received
- January 8, 2025
- Date of Event
- January 3, 2025
- Report Date
- August 28, 2025
- Manufacturer
- COOK INC
- Product Code
- LQR
- UDI-DI
- 10827002362502
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G4 - 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 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 UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B3, B5, D9. CORRECTION: E1. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE TIP OF AN N-COMPASS NITINOL STONE EXTRACTOR BROKE OFF INSIDE OF THE PATIENT DURING AN UNKNOWN PROCEDURE. AS THE TIP COULD NOT BE SEEN ON X-RAY, IT COULD NOT BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE SURGEON, THE DEVICE FRAGMENT WAS LIKELY LOCATED IN THE DUODENUM AND WOULD EVENTUALLY PASS. AS REPORTED, THE FAILURE OCCURRED AFTER THE STONE WAS REMOVED. IT IS UNKNOWN IF THE SEPARATED PORTION OF THE BASKET WAS REMOVED/PASSED FROM THE PATIENT. THE STAFF STATED THE BASKET TIP WAS NOT VISUALIZED ON X-RAY AFTER THE EVENT. IT IS UNSURE IF THE BASKET BROKE OR IF IT WAS RETRACTED "AGGRESSIVELY" INTO THE SHEATH AND THEN WAS NOT ABLE TO BE ADVANCED. THE SIZE OF THE STONE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN ADVANCING OR RETRACTING THE BASKET. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN ATTEMPTING TO REMOVE THE STONE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED BASKET DEVICE WAS RECEIVED. THE DISTAL TIP/BASKET PORTION WAS MISSING. RELEVANT MEASUREMENTS COULD NOT BE TAKEN. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE LOT FOUND NO NONCONFORMANCE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. PRODUCT LABELING REVIEW: THE PRODUCT IFU, [T_NCNSE_REV2] ¿NCOMPASS NITINOL STONE EXTRACTORS,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿-ONCE CAPTURED, SLOWLY TRANSITION THE THUMB TAB TOWARD THE ¿CLOSE¿ POSITION TO SECURE THE STONE OR DEBRIS -MAINTAIN PRESSURE ON THE THUMB TAB OF THE HANDLE TO HOLD THE STONE OR DEBRIS IN PLACE. SLOWLY RETRACT THE STONE EXTRACTOR AND THE ANCILLARY DEVICE (OR SCOPE IF UTILIZED) TOGETHER TO FACILITATE THE IMMEDIATE REMOVAL OF OBJECT FROM THE TRACT. NOTE: THE PROVIDED TUOHY-BORST ADAPTER MAY BE TIGHTENED ONCE THE STONE IS CAPTURED TO SECURE THE POSITION OF THE STONE EXTRACTOR DURING REMOVAL. THIS ADAPTER WILL NOT LOCK THE BASKET ON THE STONE OR DEBRIS BUT WILL SECURE THE POSITION OF THE SHEATH RELATIVE TO THE ANCILLARY DEVICE. NOTE: DO NOT USE EXCESSIVE FORCE ON THE HANDLE. DOING SO MAY RESULT IN DAMAGE TO THE DEVICE, INCLUDING BUT NOT LIMITED TO, BASKET SEPARATION OR INABILITY TO OPEN/CLOSE DEVICE.¿ EVIDENCE GATHERED UPON REVIEW OF THE DMR, PRODUCT IFU, DHR, AND DEVICE FAILURE ANALYSIS, THERE IS NO INDICATION THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. IT¿S POSSIBLE THAT THE DEVICE BECAME DAMAGED DURING STONE REMOVAL RESULTING IN THE TIP BREAKAGE, HOWEVER THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
IT WAS REPORTED THAT THE TIP OF AN N-COMPASS NITINOL STONE EXTRACTOR BROKE OFF INSIDE OF THE PATIENT DURING AN UNKNOWN PROCEDURE. AS THE TIP COULD NOT BE SEEN ON X-RAY, IT COULD NOT BE RETRIEVED AND WAS LEFT INSIDE THE PATIENT. ACCORDING TO THE SURGEON, THE DEVICE FRAGMENT WAS LIKELY LOCATED IN THE DUODENUM AND WOULD EVENTUALLY PASS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
ADDITIONAL INFORMATION WAS PROVIDED. AS REPORTED, THE FAILURE OCCURRED AFTER THE STONE WAS REMOVED. IT IS UNKNOWN IF THE SEPARATED PORTION OF THE BASKET WAS REMOVED/PASSED FROM THE PATIENT. THE STAFF STATED THE BASKET TIP WAS NOT VISUALIZED ON X-RAY AFTER THE EVENT. IT IS UNSURE IF THE BASKET BROKE OR IF IT WAS RETRACTED "AGGRESSIVELY" INTO THE SHEATH AND THEN WAS NOT ABLE TO BE ADVANCED. THE SIZE OF THE STONE IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN ADVANCING OR RETRACTING THE BASKET. IT IS UNKNOWN IF THERE WAS ANY RESISTANCE WHEN ATTEMPTING TO REMOVE THE STONE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1910718 | N-COMPASS NITINOL STONE EXTRACTOR | LQR DISLODGER, STONE BILIARY | LQR | COOK INC | G36250 | 16271196 | 10827002362502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |