FROVA INTUBATING INTRODUCER
Report
- Report Number
- 3002808486-2018-00729
- Event Type
- Injury
- Date Received
- June 22, 2018
- Date of Event
- December 11, 2017
- Report Date
- August 21, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- LRC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K): K161813. INVESTIGATION IS STILL IN PROGRESS.
THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. ALL INFORMATION FOR THIS EVENT WAS PREVIOUSLY SUBMITTED 22JUN2018, 19JUN2018 AND 21AUG2018.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). B3) DATE OF EVENT HAVE BEEN CORRECTED FROM 19DEC2017 TO 11DEC2017 G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 INVESTIGATION IS STILL IN PROGRESS 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.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). REGISTRATION NO.: 3005580113 H6) EC METHOD CODE: 4109 - HISTORICAL DATA ANALYSIS. 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY. 4114 - DEVICE NOT RETURNED. SUMMARY OF INVESTIGATIONAL FINDINGS: NO PRODUCT WAS RETURNED TO ASSIST THE INVESTIGATION, BUT IT IS REPORTED THAT THE PEELING WAS NOTICED DURING PLACEMENT OF A DOUBLE LUMEN TUBE AND THE FROVA INTRODUCER IS DESIGNED FOR PLACEMENT OF A SINGLE LUMEN TUBE ONLY". NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ¿AFTER INTUBATION OF THE TRACHEA WHILE PERFORMING A BRONCHOSCOPY, A SMALL FRAGMENT OF A PLASTIC MATERIAL WAS DETECTED AT BRONCHIAL LEVEL, PRESUMABLY DETACHED FROM THE INTERIOR OF THE INTRODUCER TUBE (NO DETERIORATION WAS FOUND EXTERNALLY). SINCE IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THE LUNG WAS REMOVED, IT HAD NO CONSEQUENCES FOR THE PATIENT, BUT IT COULD HAVE HAD A DIFFERENT OUTCOME UNDER OTHER CIRCUMSTANCES. APPARENTLY, THE SAME OCCURRENCE HAS BEEN PREVIOUSLY OBSERVED (DETAILS UNKNOWN).¿ AFTER INTUBATION OF THE TRACHEA, WHEN CARRYING OUT BRONCHOSCOPIC INSPECTION, IT APPEARS AT THE BRONCHIAL SPLINTER / SCRAPE LEVEL OF THE PLASTIC MATERIAL, PRESUMABLY DETACHED FROM THE INTERIOR OF THE INTRODUCER ROD (EXTERNALLY THERE WAS NO DETERIORATION); GIVEN THAT IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THAT THE LUNG WAS EXPLANTED, IT HAD NO CONSEQUENCES FOR THE PATIENT, WHICH WOULD HAVE OCCURRED IN OTHER CIRCUMSTANCES DURING THE IOT THEY HAD DIFFICULTIES TO INSERT THE DOUBLE-LUMEN TUBE SO PROCEEDED TO USE A FROVA FIRST AND THROUGH THE FROVA, THE DOUBLE-LUMEN TUBE. THE PROCEDURE WAS PERFORMED IN A SINGLE ATTEMPT AND WITHOUT ANY DIFFICULTY. THE PLACEMENT OF THE TUBE OF DOUBLE LIGHT WAS CHECKED WITH THE FIBROSCOPE, OBJECTIFYING IN THE LEFT BRONCHIAL LIGHT A STRANGE BLUE BODY OF THE SAME COLOR AS THE FROVA THEY HAD JUST USED, SO HE CAREFULLY OBSERVED IT TO CONFIRM IF ANY PART WAS MISSING, HOWEVER, IT SEEMED TOTALLY INTEGRATED. WHEN EXPLANTING THE LUNG, IT WAS PROCEEDED TO EXTRACT THE MATERIAL AND IT WAS PART OF THE FROVA. ABOUT THE PREVIOUS INCIDENCES NO MORE INFORMATION CAN BE GIVEN. THE NURSE STAFF OF THE THEATRE ROOM TOLD THAT THIS PROBLEM HAPPENED BEFORE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. SINCE IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THE LUNG WAS REMOVED, IT HAD NO CONSEQUENCES FOR THE PATIENT
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ¿AFTER INTUBATION OF THE TRACHEA WHILE PERFORMING A BRONCHOSCOPY, A SMALL FRAGMENT OF A PLASTIC MATERIAL WAS DETECTED AT BRONCHIAL LEVEL, PRESUMABLY DETACHED FROM THE INTERIOR OF THE INTRODUCER TUBE (NO DETERIORATION WAS FOUND EXTERNALLY). SINCE IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THE LUNG WAS REMOVED, IT HAD NO CONSEQUENCES FOR THE PATIENT, BUT IT COULD HAVE HAD A DIFFERENT OUTCOME UNDER OTHER CIRCUMSTANCES. APPARENTLY, THE SAME OCCURRENCE HAS BEEN PREVIOUSLY OBSERVED (DETAILS UNKNOWN).¿ AFTER INTUBATION OF THE TRACHEA, WHEN CARRYING OUT BRONCHOSCOPIC INSPECTION, IT APPEARS AT THE BRONCHIAL SPLINTER / SCRAPE LEVEL OF THE PLASTIC MATERIAL, PRESUMABLY DETACHED FROM THE INTERIOR OF THE INTRODUCER ROD (EXTERNALLY THERE WAS NO DETERIORATION); GIVEN THAT IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THAT THE LUNG WAS EXPLANTED, IT HAD NO CONSEQUENCES FOR THE PATIENT, WHICH WOULD HAVE OCCURRED IN OTHER CIRCUMSTANCES DURING THE IOT THEY HAD DIFFICULTIES TO INSERT THE DOUBLE-LUMEN TUBE SO PROCEEDED TO USE A FROVA FIRST AND THROUGH THE FROVA, THE DOUBLE-LUMEN TUBE. THE PROCEDURE WAS PERFORMED IN A SINGLE ATTEMPT AND WITHOUT ANY DIFFICULTY. THE PLACEMENT OF THE TUBE OF DOUBLE LIGHT WAS CHECKED WITH THE FIBROSCOPE, OBJECTIFYING IN THE LEFT BRONCHIAL LIGHT A STRANGE BLUE BODY OF THE SAME COLOR AS THE FROVA THEY HAD JUST USED, SO HE CAREFULLY OBSERVED IT TO CONFIRM IF ANY PART WAS MISSING, HOWEVER, IT SEEMED TOTALLY INTEGRATED. WHEN EXPLANTING THE LUNG, IT WAS PROCEEDED TO EXTRACT THE MATERIAL AND IT WAS PART OF THE FROVA. ABOUT THE PREVIOUS INCIDENCES NO MORE INFORMATION CAN BE GIVEN. THE NURSE STAFF OF THE THEATRE ROOM SAID THAT THIS PROBLEM HAPPENED BEFORE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. SINCE IT OCCURRED IN A CASE OF LUNG TRANSPLANTATION AND THE LUNG WAS REMOVED, IT HAD NO CONSEQUENCES FOR THE PATIENT
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 |
|---|---|---|---|---|---|---|---|
| 471130 | FROVA INTUBATING INTRODUCER | LRC INSTRUMENT, ENT MANUAL SURGICAL | LRC | WILLIAM COOK EUROPE | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |