MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITHOUT SPIKE

Catalog Number	DBF-2.4-230-S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect medical device: common name- forceps, biopsy, non-electric.(b)(4).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".Prior to distribution, all captura biopsy forceps without 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.
Event or Problem Description
During a biopsy procedure, the physician used a cook captura biopsy forceps without spike.The forceps fell apart inside the patient.The black covering on the end of the forceps came off inside the patient, and the forceps failed to function [difficult to open].The physician had to withdraw the endoscope to remove the forceps.They were also able to retrieve the black covering by using another forceps.A section of the device did not remain inside the patient¿s body.The detached portion of the covering was retrieved by forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
The device was received for evaluation on 20-july-2018.Our evaluation of the returned device was unable to confirm the report of a detached portion of the cook forceps device as originally reported by the customer.The "detached portion" was also returned and it was confirm to be of unknown origin.The returned portion said to be retrieved from the patient was not a portion of any cook device.Further, the returned cook forceps device was intact and no other reportable damage was found.Based on the device evaluation, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This follow up emdr is being sent to cancel the initial emdr.See section h10- additional manufacturer narrative-notes for this justification.

• Brand Name: CAPTURA BIOPSY FORCEPS WITHOUT SPIKE
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7664490
• Report Number: 1037905-2018-00304
• Device Sequence Number: 1524056
• Product Code: PTS
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)210209(10)W4030754
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2021
• Device Catalogue Number: DBF-2.4-230-S
• Device Lot Number: W4030754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX 90K SERIES GASTROSCOPE; PENTAX 90K SERIES GASTROSCOPE
• Outcome Attributed to Adverse Event: Required Intervention