MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA MINI BIOPSY FORCEPS W/O SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G53006

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and returned to the approved supplier.The investigation is on-going.A follow-up emdr will be provided with product evaluation information.

Event Description

In preparation for a gastric biopsy, the user prepared the captura mini biopsy forceps w/o spike.The user reported that they opened the package and found the cup was "bent" prior to patient contact.A photo was provided and depicts a gap in the teeth when the cup is closed [subject of this report].This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Information regarding suspect medical device section common device name: not available.Regulation name: hemostatic device for intraluminal gastrointestinal use.Product code: qau information regarding pma/510(k): den170015.Investigation evaluation: the photo attached from user shows the cups and there is a slight gap in the cups.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with no sign of damage to the sheath.The cups opened/closed as designed however the cups had a gap in the cups when fully closed.Under magnification the cups are not misaligned, however one side of the cups does not fully close.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 device was returned to the supplier.The supplier provided the following: visual evaluation: the device was visually evaluated.No defects to the handle or catheter were noted.The device was also visually evaluated for "cups are not misaligned but one side has a gap an not fully closing/meshing".The handle was manipulated to simulate the cups open position.The handle was manipulated again to simulate closed position and a minimal gap was noted.Upon further examination of the cups, using additional magnification, a small burr was noted on one side of the jaws preventing complete closure.The reported event for "bent cup" was not confirmed.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u-shaped, and two (2) 8" loop coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.Additional comments: the reported event for "cups are not misaligned but one side has a gap and not fully closing/meshing" was confirmed.The device history records for process work order (pwo) were reviewed.The assembly orders (ao) involved were reviewed.There were no relevant defects noted in the manufacturing and/or fqc checklist records.Investigation conclusion: the supplier provided the following: the assignable cause was human error.The production manager will be notified and asked to share the complaint details with the operators associated with this process.The evaluation determined that a burr was present on one of the cups and created a gap.Following assembly of the cups, the operators are required to buff the inside of the cups to remove the matte finish and produce a shiny finish.Burrs are the result of insufficient buffing.Prior to distribution, all captura mini biopsy forceps w/o 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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.The photo attached from user shows the cups and there is a slight gap in the cups.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with no sign of damage to the sheath.The cups opened/closed as designed however the cups had a gap in the cups when fully closed.Under magnification the cups are not misaligned however one side of the cups does not fully close.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 device was returned to the supplier.The supplier provided the following: visual evaluation: the device was visually evaluated.No defects to the handle or catheter were noted.The device was also visually evaluated for "cups are not misaligned but one side has a gap an not fully closing/meshing".The handle was manipulated to simulate the cups open position.The handle was manipulated again to simulate closed position and a minimal gap was noted.Upon further examination of the cups, using additional magnification, a small burr was noted on one side of the jaws preventing complete closure.The reported event for "bent cup" was not confirmed.Update 04 february 2021: further examination of the device under magnification observed a nick of the biting edge of the cup.Rather than a burr as initially reported, the gap is a portion of the edge of the cup that was inadvertently nicked during the buffing process.Functional evaluation: the device was functionally evaluated.During testing, with the device held in straight, u-shaped, and two (2) 8" loop coiled positions, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.Additional comments: the reported event for "cups are not misaligned but one side has a gap and not fully closing/meshing" was confirmed.The device history records for process work order (pwo) manufactured april 2020 were reviewed.The assembly orders (ao) manufactured april 2020 was reviewed.The ao manufactured april 2020 was reviewed.The ao manufactured april 2020 was reviewed.There were no relevant defects noted in the manufacturing and/or final quality check (fqc) checklist records.Investigation conclusion: the supplier provided the following: the assignable cause was human error.The production manager will be notified and asked to share the complaint details with the operators associated with this process.The supplier provided a revised their response on 10 february 2021.The supplier provided the additional comment: "the complaint was initially closed on 05 january 2021.Further discussion of the event prompted an additional evaluation of the cups on 04 february 2021.The evaluation determined that a portion of the cup edge was unintentionally removed by the buffing process." prior to distribution, all captura mini biopsy forceps w/o 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.

• Brand Name: CAPTURA MINI BIOPSY FORCEPS W/O 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 Key: 11002846
• MDR Text Key: 221280749
• Report Number: 1037905-2020-00550
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002530065
• UDI-Public: (01)00827002530065(17)230709(10)W4363289
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: G53006
• Device Catalogue Number: DBF-1.8-160-S
• Device Lot Number: W4363289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1