MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA SERRATED LARGE FORCEP-NO SPIKE; FCL, FORCEPS, BIOPSY, NON-ELECTRIC

Catalog Number DBF-2.4SL-230-40-S

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation of the used device was not performed in response to this report because the used product said to be involved was not provided to cook for evaluation.The report could not be confirmed.Twelve sealed devices were returned from the lot number provided in the report.The label matches the product returned.These devices were received on 10/28/2015 and the evaluation of these devices is still on-going.A follow up report will be generated once the evaluation is completed.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: 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.We cannot adequately determine a root cause at this time because the evaluation of the sealed devices is still ongoing.Prior to distribution, all captura serrated large forcep-no 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 Description

On (b)(6) 2015 during a colonoscopy procedure on a patient of unknown age and gender, the physician used a cook captura serrated large forcep-no spike.The physician introduced the forceps down the scope, opened the cups and when they attempted to close the cups for a biopsy bite, the cups fell off.The cups were retrieved with a roth net.Another forcep was used to continue, however, it is unclear if it was a different lot number.No harm to the patient and no additional procedures or intervention was required due to this occurrence.

Manufacturer Narrative

Investigation evaluation: a product evaluation of the used device was not performed in response to this report because the used product said to be involved was not provided to cook for evaluation.The report could not be confirmed.Twelve sealed devices were returned from the lot number provided in the report.The label matches the product returned.Each of the twelve (12) sealed devices was subjected to a close visual inspection for any abnormalities that could lead to cup detachment.No abnormality was observed in any of the devices.Each device was then inserted into a pfc-130l endoscope in a simulated upper gastrointestinal (gi) position.Six biopsies were taken with each device.No issues were noted during this functional test.A close visual inspection was performed on each device after the biopsies were taken to inspect for any damage to the devices.No damage was observed especially any that could have contributed to the observation of the user of cup detachment.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: we could not conduct a complete investigation because the used product said to be involved was not returned for evaluation.A definitive cause for this observation by the user could not be determined because the actual use conditions could not be duplicated in the laboratory setting.In addition, 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.The returned sealed devices functioned as expected.This limits our ability to conclusively determine a cause.Prior to distribution, all captura serrated large forcep - no 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 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5205623
• MDR Text Key: 30569036
• Report Number: 1037905-2015-00477
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DBF-2.4SL-230-40-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1