MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITH SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number	DBF-2.4-230SP-S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our initial evaluation of the product said to be involved was unable to confirm the report as described.The forceps would open and close with the expected amount of force.The cups were visually inspected under magnification and a slight cup misalignment was observed, however, we do not believe the cups of this device are misaligned more than the manufacturer's specification.The device has been returned to the approved supplier for further evaluation.A follow up report will be sent when evaluation is complete.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The size of tissue sample or biopsy to be excised can be controlled by how the user handles the forceps.If excessive pressure was applied during advancement into the tissue or during handle manipulation, this could have contributed to the reported observation.The instructions for use direct the user to advance the forceps into the tissue at the desired biopsy site.Then the user is instructed to close the forceps around the tissue while using slight pressure on the handle.The user is instructed to maintain gentle handle pressure to keep the cups closed and gently withdraw the forceps from the site.Instructions for use warning: these single-use forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients.Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place.The instructions for use lists potential complications as: those associated with gastrointestinal endoscopy include but are not limited to: perforation, bleeding or hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest cardiac arrhythmia or arrest.Prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an endoscopy procedure, the physician used a cook captura biopsy forceps with spike.The device tore the tissue instead of taking a bite.It was not a clean bite.It did not cause excessive bleeding.
Additional Manufacturer Narrative
This emdr follow up report is being submitted to provide the results of the supplier evaluation received on 04/05/2016.Investigation evaluation: our initial evaluation of the product said to be involved was unable to confirm the report as described.The forceps would open and close with the expected amount of force.The cups were visually inspected under magnification and a slight cup misalignment was observed, however, we do not believe the cups of this device are misaligned more than the manufacturer's specification.The device was returned to the approved supplier for further evaluation.The supplier provided the following information: one device from the reported event was returned in a zip type bag with proof of decontamination.Evaluation of the returned forceps determined that the reported complaint could not be verified.The forceps cups are not misaligned and the device passes the final quality control (fqc) checklist.The visible cup wall thickness was measured to be within specification.The device was opened and closed multiple times to confirm proper cup alignment.When put through the tortuous path endoscope, the cups remained aligned.The device link wires were properly positioned as determined under magnification.The distance between fork arms was measured to be within specification.Under magnification, no anomalies were discovered.The device meets fqc checklist requirements.The device history records for the packaging work orders (pwo) were reviewed.These assembly orders (ao) were manufactured in november 2015.No relevant defects were noted in the records.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: the customer experienced issue of "device tore tissue" could not be confirmed.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The size of tissue sample or biopsy to be excised can be controlled by how the user handles the forceps.If excessive pressure was applied during advancement into the tissue or during handle manipulation, this could have contributed to the reported observation.The instructions for use direct the user to advance the forceps into the tissue at the desired biopsy site.Then the user is instructed to close the forceps around the tissue while using slight pressure on the handle.The user is instructed to "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." instructions for use warning: "these single-use forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients.Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place." the instructions for use lists potential complications as: "those associated with gastrointestinal endoscopy include but are not limited to: perforation, bleeding or hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest." prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: CAPTURA BIOPSY FORCEPS WITH SPIKE
• Common Device Name: FCL, FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5471135
• Report Number: 1037905-2016-00045
• Device Sequence Number: 230371
• Product Code: FCL
• UDI-Device Identifier: 00827002315853
• UDI-Public: (01)00827002315853(17)181215(10)W3660928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DBF-2.4-230SP-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR