MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-01-20 for CUP BIOPSY FORCEPS 220130 manufactured by Cook Inc.
[188657055]
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.
Patient Sequence No: 1, Text Type: N, H10
[188657056]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00157 |
| MDR Report Key | 9607281 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-20 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUP BIOPSY FORCEPS |
| Product Code | OCZ |
| Date Received | 2020-01-20 |
| Catalog Number | 220130 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-20 |