N
Patient 1
COMMON NAME/PROCODE: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED; OCZ. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
MAUDE MDR 9607281
- MDR report key
- 9607281
- Report number
- 1820334-2020-00157
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. JENNIFER CANADA
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-20 | 0 | 1. O |
Event Narratives#
D
Patient 1
AS REPORTED IN 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 (PATIENT IDENTIFIER 290203 AND THIS REPORT), COOK MEDICAL INC) OR BIGOPSY BACKLOADING BIOPSY FORCEPS (PATIENT IDENTIFIER 289267) (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 CUP BIOPSY 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. THIS CASE REPORTS POTENTIAL CASE(S) OCCURRING IN THE JAPAN. PATIENT IDENTIFIER (B)(6) REPORTS POTENTIAL CASE(S) OCCURRING IN THE US.