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

Model Number	G56125
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.
Event or Problem Description
During an unknown number of biopsy procedures, the physician(s) used cook captura serrated forceps without spike.It was reported that the endoscopy surgeons are having problems with the captura forceps.They are having to open two (2) to three (3) forceps per case.Some are bending at the tip and some have wires coming out of the tip ["tromboning"].There was no reportable information at this time.The device returned as a representative sample from the user facility, was received for evaluation on (b)(6) 2019 and there was a gap in the forceps cups when in the closed position.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.
Event or Problem Description
During an unknown number of biopsy procedures, the physician(s) used cook captura serrated forceps without spike.It was reported that the endoscopy surgeons are having problems with the captura forceps.They are having to open two (2) to three (3) forceps per case.Some are bending at the tip and some have wires coming out of the tip ["tromboning"].There was no reportable information at this time.The device returned as a representative sample from the user facility, was received for evaluation on 03-jul-2019 and there was a gap in the forceps cups when in the closed position.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.
Additional Manufacturer Narrative
Continued from section e3 occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that there was a gap in the cups.During a visual evaluation, it was noted that the link wires were protruding from the housing and severely bent.During a functional test, the handle was easy to manipulate.The cups would not fully close, there was a gap between the teeth.When the cups were closed, they would bend to one side.The cups did not fully open.It seems that the bent link wires did not allow the cups full range of motion.The device was not functionally tested down an endoscope due to the condition it was returned in.No other anomalies were detected with the device.The device was sent back to the supplier for a full evaluation.The supplier provided the following: device 1: the device was visually evaluated.No defects to the handle or catheter were noted.The link wires were bent and protruding from the housing.The device was functionally evaluated.During testing, with the device held in straight, u­ shaped, and three (3), eight (8) inch loop coiled positions, respectively, it was confirmed that the device did not operate properly when the handle was manipulated.The device did not fully open or close.Rather, the cups rotated about the axis of the pivot pin when the handle was manipulated.When the handle was manipulated to the closed position, a gap was noted between the cups and they would not close completely.The reported event for "bent tip/ wires" was confirmed.The device was disassembled to evaluate the link wires and solder connection.Based on a side profile, the link wires were bent and protruding from the housing and could not be evaluated for even positioning.The solder connection was intact.Device 2: the device was visually evaluated.No defects to the handle, catheter, or cups assembly were noted.During testing, with the device in straight and u­ shaped positions, and coiled in three (3), eight (8) inch loops, respectively, it was confirmed that the device operated properly when the handle was manipulated.The device opened and closed as designed.The reported event for "bent tip/ wires" was not confirmed.The device was disassembled to evaluate the link wires and solder connection.The link wires were determined to be positioned evenly and the solder connection was intact.The device history records for were reviewed.The assembly order was manufactured in february 2019.The manufacturing records and/or final quality control checklist did not indicate relevant defects.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 bent tip and wires protruding from tip was confirmed for the used device.The assignable cause is unknown.All devices receive a 100% inspection prior to shipment.The sealed device (unused) did not have any defects." the instructions for use (ifu) includes the following to ensure proper use of the device: "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." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps 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.

• Brand Name: CAPTURA SERRATED FORCEPS W/O SPIKE
• Common Device Name: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8831466
• Report Number: 1037905-2019-00418
• Device Sequence Number: 310920
• Product Code: PTS
• UDI-Device Identifier: 00827002561250
• UDI-Public: (01)00827002561250(17)220304(10)W4186920
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: G56125
• Device Catalogue Number: DBF-2.4SN-230-S
• Device Lot Number: W4186920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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: OLYMPUS 190 GASTROSCOPE AND COLONOSCOPE