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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC
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COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC Back to Search Results
Catalog Number DBF-2.4SL-230SP-40-S
Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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 investigation is on-going.A follow-up medwatch report will be provided within 30 days of submission of this report with completed investigation information.
 
Event Description
During an endoscopic procedure, the physician used cook captura serrated large forceps-spike.The forceps are taking too deep of bites (subject of this report).The following was reported on 01-june-2018: "it [tearing and bleeding] was noticed in both the colon and esophagus.Deep bites were needed for barrets [esophageal condition].The bites were too big on colitis [colon inflammation] surveillance and caused bleeding.Screening colonoscopies with biopsies caused excessive bleeding and some patients had to come back to get clipped [clip application for hemostasis].This happened to four (4) patients within a two (2) week span, none of which who were on anticoagulants (subject of this report, and see related mdr1037905-2018-00261, mdr 1037905-2018-00263)." updated information was received from the physician on 15-june-2018: "all cases were used with the cook sl forceps.Four (4) patients were clipped prophylactically [as a preventive measure] (see related mdr 1037905-2018-00263) after two (2) patients were previously admitted to the hospital (subject of this report and related mdr 1037905-2018-00261).The first patient admitted required a transfusion (see related mdr 1037905-2018-00261) and the second patient stopped bleeding on their own (subject of this report).These two (2) cases happened before the four (4) that required prophylactic clipping (see related mdr 1037905-2018-00263).A section of the device did not remain inside the patient¿s body.The patient was hospitalized due to this occurrence, but required no further procedures.According to the initial reporter, it is unknown if the patient experienced any adverse effects due to this occurrence.
 
Manufacturer Narrative
Investigation evaluation; a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use state the following in regards to product inspection: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." the instructions for use state: "using slight pressure on handle, close forceps around tissue or object.Note: it is not necessary to apply excessive pressure to cleanly excise tissue." prior to distribution, all captura serrated large forcep-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 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.
 
Event Description
During an endoscopic procedure, the physician used cook captura serrated large forceps-spike.The forceps are taking too deep of bites (subject of this report).The following was reported on 01-june-2018: "it [tearing and bleeding] was noticed in both the colon and esophagus.Deep bites were needed for barrets [esophageal condition].The bites were too big on colitis [colon inflammation] surveillance and caused bleeding.Screening colonoscopies with biopsies caused excessive bleeding and some patients had to come back to get clipped [clip application for hemostasis].This happened to four (4) patients within a two (2) week span, none of which who were on anticoagulants (subject of this report, and see related mdr1037905-2018-00261, mdr 1037905-2018-00263)." updated information was received from the physician on 15-june-2018: "all cases were used with the cook sl forceps.Four (4) patients were clipped prophylactically [as a preventive measure] (see related mdr 1037905-2018-00263) after two (2) patients were previously admitted to the hospital (subject of this report and related mdr 1037905-2018-00261).The first patient admitted required a transfusion (see related mdr 1037905-2018-00261) and the second patient stopped bleeding on their own (subject of this report).These two (2) cases happened before the four (4) that required prophylactic clipping (see related mdr 1037905-2018-00263).A section of the device did not remain inside the patient¿s body.The patient was hospitalized due to this occurrence, but required no further procedures.According to the initial reporter, it is unknown if the patient experienced any adverse effects due to this occurrence.
 
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Brand Name
CAPTURA SERRATED LARGE FORCEP-SPIKE
Type of Device
FCL, FORCEPS, BIOPSY, NON-ELECTRIC
Manufacturer (Section D)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
MDR Report Key7612101
MDR Text Key111432986
Report Number1037905-2018-00262
Device Sequence Number1
Product Code FCL
UDI-Device Identifier00827002560765
UDI-Public(01)00827002560765(17)200830(10)W3910945
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 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/30/2020
Device Catalogue NumberDBF-2.4SL-230SP-40-S
Device Lot NumberW3910945
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OLYMPUS ENDOSCOPE, UNKNOWN MODEL
Patient Outcome(s) Hospitalization;
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