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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-NO SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC
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COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-NO SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC Back to Search Results
Catalog Number DBF-2.4SL-230-40-S
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.During a functional test, when the handle was manipulated, the forceps cups opened, but would not close.A visual inspection was performed on the device, and the handle drive wire appears to be separated from the handle spool.During our evaluation, a pair of tweezers was used to manipulate the drive wire to determine if the separated handle spool could be the reason that the cups would not close.When the drive wire is manipulated, the forceps cups would open and close as intended.The separation between the handle spool and the drive wire is causing the cups not to close.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 biopsy procedure, the physician used a cook captura serrated large forcep-no spike.The forceps would not open and close correctly.The device is broken where the drive wire connects to the handle.They put it down the endoscope and it would not open or close.They opened a new device to complete the procedure.
 
Event Description
During a biopsy procedure, the physician used a cook captura serrated large forcep-no spike.The forceps would not open and close correctly.The device is broken where the drive wire connects to the handle.They put it down the endoscope and it would not open or close.They opened a new device to complete the procedure.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 confirmed the report.During a functional test, when the handle was manipulated, the cups opened, but would not close.A visual inspection was performed on the device, and the handle drive wire appears to be separated from the handle spool.During our evaluation a pair of tweezers was used to manipulate the drive wire to determine if this could be the reason the cups would not close.When the drive wire was manipulated, the forceps cups would open and close as intended.The separation between the handle spool and the drive wire is causing the cups not to close.The device was sent back to the supplier for further evaluation.The supplier provided the following evaluation: one (1) device from the reported event was returned in a zip type bag with proof of decontamination.The returned device was subject to a functional evaluation for the reported complaint of "would not open or close." during functional testing, with the device coiled in three (3), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated.The device opens but will not close as intended.A visual inspection was performed on the handle spool of the returned device.The control wire is separated from the handle spool.The control wire was manually manipulated causing the device cups to open and close.The root cause for failure is insufficient torqueing of screw to hold the control wire.The device history records were reviewed and found to be manufactured in january 2018.Relevant defects were noted in the manufacturing and/or final quality control 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 reported issue for "would not open and close'" was confirmed.The root cause was believed to be insufficient torqueing of the screw to hold the control wire.The operators involved will be advised of the complaint.Prior to distribution, all captura serrated large forceps- no spike are subjected to a visual inspection and functional test to ensure proper workability.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.
 
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Brand Name
CAPTURA SERRATED LARGE FORCEP-NO SPIKE
Type of Device
FCL, FORCEPS, BIOPSY, NON-ELECTRIC
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key7549325
MDR Text Key109404100
Report Number1037905-2018-00227
Device Sequence Number1
Product Code FCL
UDI-Device Identifier00827002560598
UDI-Public(01)00827002560598(17)210213(10)W4033080
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDBF-2.4SL-230-40-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/30/2018
Device Age2 MO
Event Location Hospital
Date Manufacturer Received05/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS ENDOSCOPE, UNKNOWN MODEL; OLYMPUS ENDOSCOPE, UNKNOWN MODEL
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