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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
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COOK ENDOSCOPY CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT Back to Search Results
Model Number G50697
Device Problem Dull, Blunt (2407)
Patient Problems Tissue Damage (2104); No Consequences Or Impact To Patient (2199)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.During a visual inspection it was noted that the forceps housing was slightly bent to one side.There was a gap between the base of the forceps housing and the coil catheter, and there was also a gap between the forceps housing where it comes together around the coil catheter.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups opened and closed as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps took a bite of the simulated tissue as expected.The device was sent back to the supplier for further evaluation.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.The product was returned to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.
 
Event Description
During a colonoscopy procedure, the physician used a cook captura pro biopsy forceps with spike.The physician took a bite and stated that some of the tissue ripped/tore as opposed to the clean bite these forceps normally take.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Event Description
During a colonoscopy procedure, the physician used a cook captura pro biopsy forceps with spike.The physician took a bite and stated that some of the tissue ripped/tore as opposed to the clean bite these forceps normally take.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.During a visual inspection, it was noted that the forceps housing was slightly bent to one side.There was a gap between the base of the forceps housing and the coil catheter, and there was also a gap between the forceps housing where it comes together around the coil catheter.During the evaluation of the device, the forceps were advanced down an olympus 2.8 mm channel endoscope.When the handle was manipulated, the forceps cups would open and close as intended.A functional test was performed by taking a biopsy sample of simulated tissue.The forceps would take a bite of the simulated tissue as expected.The device was sent back to the supplier for further evaluation.The supplier provided the following: "the device was visually evaluated.The finished device passed the final quality control (fqc) checklist except for the straightness.The tip of the device was bent slightly.The forceps forks were no longer in a straight line with the cable, however this is to be expected after use.The gaps between the mating surfaces of the forceps forks were acceptable.The device tip passed the specification.The device was functionally evaluated.To simulate the worst case tortuous path, the device was coiled in three (3), 8" loops.The device operated properly when the handle was manipulated.The device opened and closed and took a clean bite of simulated tissue.The reported defect for tissue ripped/tore, was not confirmed.The device was returned in the expected condition and functioned as intended.The device history records for were reviewed.The assembly order was manufactured in december 2018.There were no relevant defects noted in the manufacturing and/or fqc checklist 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 conclusion: the supplier provided the following: the user's complaint that the tissue ripped/tore was not confirmed.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 (ifu) direct the user to: ¿advance forceps to biopsy or retrieval site, then open cups and advance into tissue to be biopsied or objected to be retrieved.Using slight pressure on handle, close forceps around tissue or object.Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site.¿ the ifu warns: "these single-use biopsy 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." prior to distribution, all captura pro biopsy forceps with spike are subjected to a visual inspection and functional testing 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 rare.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.
 
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Brand Name
CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE
Type of Device
PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key8755986
MDR Text Key152079614
Report Number1037905-2019-00366
Device Sequence Number1
Product Code PTS
UDI-Device Identifier00827002506978
UDI-Public(01)00827002506978(17)211204(10)W4153778
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2021
Device Model NumberG50697
Device Catalogue NumberBF-2.4SL-230SP-40
Device Lot NumberW4153778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Date Manufacturer Received07/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS ENDOSCOPE, UNKNOWN MODEL
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