BIGOPSY BACKLOADING BIOPSY FORCEPS
Report
- Report Number
- 3001845648-2020-00044
- Event Type
- Injury
- Date Received
- January 21, 2020
- Report Date
- April 3, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
510(K) NUMBER IS NOT APPLICABLE AS THIS IS A CLASS I DEVICE. DEVICE EVALUATION: THE BIGOPSY BACKLOADING BIOPSY FORCEPS OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL LITERATURE: TAGUCHI ET AL. 2017. OPTIMIZING RNA EXTRACTION OF RENAL PAPILLA BIOPSY TISSUE IN KIDNEY STONE FORMERS:NA NEW METHODOLOGY FOR GENOMIC STUDY. 3 DIFFERENT DEVICES WERE USED IN THIS STUDY; (PIRANHA , BOSTON SCIENTIFIC; CUP BIOPSY FORCEPS, COOK MEDICAL INC) OR BIGOPSY BACKLOADING BIOPSY FORCEPS (COOK MEDICAL INC). AUTHORS DID NOT IDENTIFY WHAT THE ADVERSE EVENTS WERE, SO IT IS NOT POSSIBLE TO DETERMINE WHICH DEVICES WERE USED IN THE CASES IN WHICH THE PATIENT EXPERIENCED AN ADVERSE EVENT. AS IT CANNOT BE CONFIRMED WHAT DEVICE WAS USED, THIS FILE IS CONSERVATIVELY BEING CREATED FOR COOK BIGOPSY® FORCEPS. THIS FILE CAPTURES 8 PERIOPERATIVE COMPLICATIONS IN JAPAN. LAB EVALUATION: N/A. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE THE BIGOPSY BACKLOADING BIOPSY FORCEPS IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED PRIOR TO DISTRIBUTION ALL THE BIGOPSY BACKLOADING BIOPSY FORCEPS DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0034-8 ¿POTENTIAL ADVERSE EVENTS INCLUDE BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL, BLEEDING, FEVER, INFECTION, NAUSEA/VOMITING, PAIN/DISCOMFORT, PERFORATION.¿ ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, IFU0034-8 ¿POTENTIAL ADVERSE EVENTS INCLUDE BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL, BLEEDING, FEVER, INFECTION, NAUSEA/VOMITING, PAIN/DISCOMFORT, PERFORATION.¿ INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT SUFFERED PERIOPERATIVE COMPLICATIONS, HARMS INCLUDE NO INTERVENTION, PHARMACOLOGICAL TREATMENT AND INTERVENTION UNDER GENERAL ANESTHESIA. FOR THE PURPOSE OF THIS FILE THE WORST CASE HARM HAS BEEN DOCUMENTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 15JAN2020--DID 16JAN2020. AS REPORTED TO CUSTOMER RELATIONS: "LITERATURE: TAGUCHI ET AL. 2017. OPTIMIZING RNA EXTRACTION OF RENAL PAPILLA BIOPSY TISSUE IN KIDNEY STONE FORMERS: A NEW METHODOLOGY FOR GENOMIC STUDY. THIS WAS A PROSPECTIVE MULTICENTER STUDY CONDUCTED AT FOUR INSTITUTIONS LOCATED IN JAPAN AND THE UNITED STATES. DURING THE STUDY PERIOD BETWEEN SEPTEMBER 2014 AND AUGUST 2016, WE INCLUDED PATIENTS BETWEEN 18 AND 80 YEARS OF AGE WITH UPPER URINARY TRACT STONES REQUIRING URS OR PCNL PROCEDURES. A TOTAL OF 90 RENAL PAPILLA TISSUE SPECIMENS FROM 49 PATIENTS. "WE OBTAINED RENAL PAPILLARY TISSUE FROM UPPER AND/OR MIDDLE CALYCES USING EITHER 3F BIOPSY FORCEPS (PIRANHA , BOSTON SCIENTIFIC; CUP BIOPSY FORCEPS (B)(4), COOK MEDICAL INC) OR BIGOPSY. BACKLOADING BIOPSY FORCEPS (B)(4) (COOK MEDICAL INC)." 4 OF 19 BIOPSY PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS IN MATCHED PAIR COMPARISON BETWEEN FLEXIBLE URETEROSCOPY WITH & WITHOUT BIOPSY. AUTHORS DID NOT IDENTIFY WHAT THE ADVERSE EVENTS WERE, SO IT IS NOT POSSIBLE TO DETERMINE WHICH DEVICES WERE USED IN THE CASES IN WHICH THE PATIENT EXPERIENCED AN ADVERSE EVENT. EVENTS PER THE ¿PERIOPERATIVE COMPLICATIONS¿ THESE ARE GRADED ¿ I HAVE PULLED THE GRADING ALSO UNDERNEATH; 1 PATIENT GRADE 1 ¿ NO INTERVENTION, 2 PATIENTS GRADE 2 PHARMACOLOGICAL TREATMENT, 1 PATIENT GRADE 3B INTERVENTION UNDER GENERAL ANAESTHESIA. 4 OF 16 BIOPSY PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS IN MATCHED PAIR COMPARISON BETWEEN PERCUTANEOUS NEPHROLITHOTOMY WITH AND WITHOUT BIOPSY. IN TABLE 4 IN THE BIOPSY GROUP 3 PATIENTS HAD GRADE 1 PERIOPERATIVE COMPLICATION ¿ NO INTERVENTION, AND 1 PATIENT HAS GRADE 2 ¿ PHARMACOLOGICAL TREATMENT. THE CLAVIEN- DINDO CLASSIFICATION IS AS FOLLOWS: GRADE I ANY DEVIATION FROM THE NORMAL POSTOPERATIVE COURSE WITHOUT THE NEED FOR PHARMACOLOGICAL TREATMENT OR SURGICAL, ENDOSCOPIC AND RADIOLOGICAL INTERVENTIONS ALLOWED THERAPEUTIC REGIMENS ARE: DRUGS AS ANTIEMETICS, ANTIPYRETICS, ANALGETICS, DIURETICS AND ELECTROLYTES AND PHYSIOTHERAPY. THIS GRADE ALSO INCLUDES WOUND INFECTIONS OPENED AT THE BEDSIDE. GRADE II REQUIRING PHARMACOLOGICAL TREATMENT WITH DRUGS OTHER THAN SUCH ALLOWED FOR GRADE I COMPLICATIONS. BLOOD TRANSFUSIONSAND TOTAL PARENTERAL NUTRITIONARE ALSO INCLUDED. GRADE III: REQUIRING SURGICAL, ENDOSCOPIC OR RADIOLOGICAL INTERVENTION IIIA: INTERVENTION NOT UNDER GENERAL ANESTHESIA. IIIB: INTERVENTION UNDER GENERAL ANESTHESIA. GRADE IV: LIFE-THREATENING COMPLICATION (INCLUDING CNS COMPLICATIONS)* REQUIRING IC/ICU-MANAGEMENT IVA: SINGLE ORGAN DYSFUNCTION (INCLUDING DIALYSIS). IVB: MULTIORGANDYSFUNCTION. THIS FILE IS BEING CREATED TO CAPTURE THE 8 PERIOPERATIVE COMPLICATIONS THAT WERE OBSERVED WITHIN THE URETEROSCOPY & PERCUTANEOUS NEPHROLITHOTOMY GROUP. AS IT CANNOT BE CONFIRMED WHAT DEVICE WAS USED, THIS FILE IS CONSERVATIVELY BEING CREATED FOR COOK BIGOPSY® FORCEPS. AS THIS LITERATURE WAS CARRIED OUT IN THE US AND JAPAN- TWO FILES HAVE BEEN CREATED TO CAPTURE EACH LOCATION AS AN EXACT LOCATION CANNOT BE CONFIRMED."
510(K) NUMBER IS NOT APPLICABLE AS THIS IS A CLASS I DEVICE. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 15JAN2020--DID 16JAN2020. AS REPORTED TO CUSTOMER RELATIONS: "LITERATURE: TAGUCHI ET AL. 2017. OPTIMIZING RNA EXTRACTION OF RENAL PAPILLA BIOPSY TISSUE IN KIDNEY STONE FORMERS: A NEW METHODOLOGY FOR GENOMIC STUDY. THIS WAS A PROSPECTIVE MULTICENTER STUDY CONDUCTED AT FOUR INSTITUTIONS LOCATED IN JAPAN AND THE UNITED STATES. DURING THE STUDY PERIOD BETWEEN SEPTEMBER 2014 AND AUGUST 2016, WE INCLUDED PATIENTS BETWEEN 18 AND 80 YEARS OF AGE WITH UPPER URINARY TRACT STONES REQUIRING URS OR PCNL PROCEDURES. A TOTAL OF 90 RENAL PAPILLA TISSUE SPECIMENS FROM 49 PATIENTS "WE OBTAINED RENAL PAPILLARY TISSUE FROM UPPER AND/OR MIDDLE CALYCES USING EITHER 3F BIOPSY FORCEPS (PIRANHA , BOSTON SCIENTIFIC; CUP BIOPSY FORCEPS (PR289998), COOK MEDICAL INC) OR BIGOPSY BACKLOADING BIOPSY FORCEPS (PR289967) (COOK MEDICAL INC)." 4 OF 19 BIOPSY PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS IN MATCHED PAIR COMPARISON BETWEEN FLEXIBLE URETEROSCOPY WITH & WITHOUT BIOPSY. AUTHORS DID NOT IDENTIFY WHAT THE ADVERSE EVENTS WERE, SO IT IS NOT POSSIBLE TO DETERMINE WHICH DEVICES WERE USED IN THE CASES IN WHICH THE PATIENT EXPERIENCED AN ADVERSE EVENT. EVENTS PER THE ¿PERIOPERATIVE COMPLICATIONS¿ THESE ARE GRADED ¿ I HAVE PULLED THE GRADING ALSO UNDERNEATH; 1 PATIENT GRADE 1 ¿ NO INTERVENTION, 2 PATIENTS GRADE 2 PHARMACOLOGICAL TREATMENT, 1 PATIENT GRADE 3B INTERVENTION UNDER GENERAL ANAESTHESIA. 4 OF 16 BIOPSY PATIENTS EXPERIENCED PERIOPERATIVE COMPLICATIONS IN MATCHED PAIR COMPARISON BETWEEN PERCUTANEOUS NEPHROLITHOTOMY WITH AND WITHOUT BIOPSY. IN TABLE 4 IN THE BIOPSY GROUP 3 PATIENTS HAD GRADE 1 PERIOPERATIVE COMPLICATION ¿ NO INTERVENTION, AND 1 PATIENT HAS GRADE 2 ¿ PHARMACOLOGICAL TREATMENT. THE CLAVIEN- DINDO CLASSIFICATION IS AS FOLLOWS: GRADE I ANY DEVIATION FROM THE NORMAL POSTOPERATIVE COURSE WITHOUT THE NEED FOR PHARMACOLOGICAL TREATMENT OR SURGICAL, ENDOSCOPIC AND RADIOLOGICAL INTERVENTIONS ALLOWED THERAPEUTIC REGIMENS ARE: DRUGS AS ANTIEMETICS, ANTIPYRETICS, ANALGETICS, DIURETICS AND ELECTROLYTES AND PHYSIOTHERAPY. THIS GRADE ALSO INCLUDES WOUND INFECTIONS OPENED AT THE BEDSIDE. GRADE II REQUIRING PHARMACOLOGICAL TREATMENT WITH DRUGS OTHER THAN SUCH ALLOWED FOR GRADE I COMPLICATIONS. BLOOD TRANSFUSIONS AND TOTAL PARENTERAL NUTRITIONARE ALSO INCLUDED. GRADE III: REQUIRING SURGICAL, ENDOSCOPIC OR RADIOLOGICAL INTERVENTION. IIIA: INTERVENTION NOT UNDER GENERAL ANESTHESIA. IIIB: INTERVENTION UNDER GENERAL ANESTHESIA. GRADE IV: LIFE-THREATENING COMPLICATION (INCLUDING CNS COMPLICATIONS)* REQUIRING IC/ICU-MANAGEMENT. IVA: SINGLE ORGAN DYSFUNCTION (INCLUDING DIALYSIS). IVB: MULTIORGANDYSFUNCTION. THIS FILE IS BEING CREATED TO CAPTURE THE 8 PERIOPERATIVE COMPLICATIONS THAT WERE OBSERVED WITHIN THE URETEROSCOPY & PERCUTANEOUS NEPHROLITHOTOMY GROUP. AS IT CANNOT BE CONFIRMED WHAT DEVICE WAS USED, THIS FILE IS CONSERVATIVELY BEING CREATED FOR COOK BIGOPSY® FORCEPS. AS THIS LITERATURE WAS CARRIED OUT IN THE US AND JAPAN- TWO FILES HAVE BEEN CREATED TO CAPTURE EACH LOCATION AS AN EXACT LOCATION CANNOT BE CONFIRMED"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75233 | BIGOPSY BACKLOADING BIOPSY FORCEPS | FCL FORCEPS, BIOPSY, NON-ELECTRIC | FCL | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |