MAUDE Adverse Event Report: COOK ENDOSCOPY UNKNOWN; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Catalog Number UNKNOWN

Device Problem Dull, Blunt (2407)

Patient Problem Hemostasis (1895)

Event Type  malfunction  

Manufacturer Narrative

The returned device was sent to the approved supplier for evaluation and the investigation is on-going.Once additional information has been received a follow-up emdr report will be provided.

Event Description

During a biopsy procedure, the physician used a cook captura pro biopsy forceps with and unknown registered product number (rpn).The following was originally reported: "once the forceps was closed on the tissue, it would not release and open back up.More tissue was pulled off than anticipated as the forceps could not be reopened, and a hemoclip was placed on the biopsy site.The procedure was able to be completed with another forceps." the following was reported on 01-oct-2019: "the device was tested prior to use and worked fine.Once down the endoscope, the device was opened and closed down on the tissue.The physician wanted to open the cups as there was too much tissue in the cups, but it would not open completely.It appeared that only one of the cups was moving with handle actuation.At that point, the physician attempted to take the biopsy but more tissue than anticipated was removed and it began to bleed more than expected.A hemoclip was placed." when the device was received for evaluation on 02-oct-2019, the device functioned as intended and no damage to the forceps was noted.The reported device was a captura pro forceps with 2.2 mm surgical edge spiked cups and length of 230 cm.However, the returned device was a captura pro 2.8 mm surgical edge spiked cups and a 230 length.The following was received from the cook sales representative on 16-oct-2019: "i spoke with the endoscopy tech today about the forceps.He said it was one of two scenarios, but wasn¿t sure which one.Scenario one, he grabbed the wrong package with the correct forceps; or scenario two, he grabbed the correct package with the wrong forceps.He did not know either way what the correct answer was." therefore, this report is being sent as an unknown captura pro forceps device with an unknown lot number.A section of the device did not remain inside the patient¿s body.The patient required placement of a hemoclip due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described.The device was returned with one cup in the open position and the other in the closed position.During a visual inspection it was noted that there was a slight gap in between the teeth on one side of the cups.During the evaluation of the device, the handle was manipulated and the forcep cups opened and closed as intended.A functional test was performed by taking a biopsy sample of simulated tissue, with the forcep coiled into three loops.The forcep took a bite of the simulated tissue as expected.There were no other anomalies detected.The device was be sent back to the supplier for further evaluation.The supplier provided the following: "one device was returned in a zip type bag with proof of decontamination.Visual evaluation: the forceps was returned for evaluation.The finished device passed the fqc checklist.The teeth are aligned; there is no gap between the cup teeth.The cups are aligned properly.Functional evaluation: the device was functionally evaluated.To simulate the worst cast tortuous path the device was coiled in three (3), eight inch (8") loops.The device operated properly when the handle was manipulated.The device closed and opened, bit and released the simulated tissue.There are bite marks, but the device released and therefore did not remove the material.No fault was found; the reported defect of "once the forceps was closed on the tissue, it would not release and open back up." could not be confirmed.The device functioned as intended." the lot number for the device that was returned was not available, and therefore the device history record review was not conducted.The device history record for the lot number on the pouch 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 user's reported issue 'cups would not open completely' was not confirmed.The observation that one of the cups exhibited a slight gap was not confirmed.All devices receive a 100% inspection prior to release and shipment.The size of tissue sample or biopsy to be excised can be controlled by how the user handles the forceps.If excessive pressure was applied during advancement into the tissue or during handle manipulation, this could have contributed to the reported observation.The instructions for use (ifu) direct the user to, ¿advance forceps to biopsy or retrieval site, then open cups and advance into tissue to be biopsied or objected to be retrieved.Using slight pressure on handle, close forceps around tissue or object.Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site.¿ the ifu warns, "these single-use biopsy forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients.Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place." prior to distribution, all captura pro¿ biopsy forceps are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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

During a biopsy procedure, the physician used a cook captura pro biopsy forceps with and unknown registered product number (rpn).The following was originally reported: "once the forceps was closed on the tissue, it would not release and open back up.More tissue was pulled off than anticipated as the forceps could not be reopened, and a hemoclip was placed on the biopsy site.The procedure was able to be completed with another forceps." the following was reported on (b)(6) 2019: "the device was tested prior to use and worked fine.Once down the endoscope, the device was opened and closed down on the tissue.The physician wanted to open the cups as there was too much tissue in the cups, but it would not open completely.It appeared that only one of the cups was moving with handle actuation.At that point, the physician attempted to take the biopsy but more tissue than anticipated was removed and it began to bleed more than expected.A hemoclip was placed." when the device was received for evaluation on (b)(6) 2019, the device functioned as intended and no damage to the forceps was noted.The reported device was a captura pro forceps with 2.2 mm surgical edge spiked cups and length of 230 cm.However, the returned device was a captura pro 2.8 mm surgical edge spiked cups and a 230 length.The following was received from the cook sales representative on (b)(6) 2019: "i spoke with the endoscopy tech today about the forceps.He said it was one of two scenarios, but wasn¿t sure which one.Scenario one, he grabbed the wrong package with the correct forceps; or scenario two, he grabbed the correct package with the wrong forceps.He did not know either way what the correct answer was." therefore, this report is being sent as an unknown captura pro forceps device with an unknown lot number.A section of the device did not remain inside the patient¿s body.The patient required placement of a hemoclip due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• 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: 9215718
• MDR Text Key: 176114663
• Report Number: 1037905-2019-00620
• Device Sequence Number: 1
• Product Code: PTS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GID-190 ENDOSCOPE
• Patient Outcome(s): Required Intervention