| Catalog Number 220130 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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 us.Patient identifier (b)(6) reports potential case(s) occurring in japan.
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Manufacturer Narrative
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Investigation ¿ evaluation: as a result of a literature review, cook became aware on 12/24/2019 of a possible incident involving a cup biopsy forceps rpn 220130 from an unknown lot.During a study conducted at multiple locations over a 2 year period, 90 renal papilla tissue specimens were obtained from 49 patients between 18 and 80 years of age with upper urinary tract stones requiring urs or pcnl procedures.4 of 19 biopsy patients experienced perioperative complications.3 patients had grade 1 perioperative complication ¿ no intervention, and 1 patient has grade 2 ¿ pharmacological treatment.The study was conducted using cook medical 3f biopsy forceps and boston scientific piranha cup biopsy forceps.The literature was not specific as to which devices were used for the 4 observed perioperative complications.As it cannot be confirmed what device was used, this file is conservatively being created for cook 3f 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.A document based investigation was performed including a review of the instructions for use and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specifications.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.No product returned.The lot number was not known, therefore no similar product from the same lot could be obtained for investigation.There was not enough information available to determine the nature of the complaint issue or determine a cause.Based on the limited information available, the likely contributing factors include patient anatomy, patient condition (pre-existing conditions/co-morbidities), procedural, and user technique.Since there were no reported product malfunctions, it is not likely that the events were related to the device.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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.
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Event Description
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No new patient or event information to report.
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Search Alerts/Recalls
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