MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 170051

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic gastrectomy, a needle fragment partially broke off while the surgeon was suturing the stomach wall.The remaining tip of approx.2mm was left on the device.The remaining fragment was unable to be found.The surgeon proceeded with the case thereafter.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found that the needle was broken and misloading witness marks were on the loading slot of the needle.Microscopic inspection noted flat pin marks on the needle cones.It was reported that the needle fell out of the jaws of the device and broke into separate pieces.A component disengaged from the device into the surgical cavity.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Broken needle can occur if the needle was not loaded properly or when the needle was forced into an obstacle.This condition may also occur if excess pressure was exerted on the needle or the attached suture while the jaws were in the open position.In these situations, the needle may flex and ultimately break.Improperly loaded needle can occur if either the endo stitch dlu had incorrect orientation or the endo stitch suturing device was held with the printed information facing down when the needle was loaded in the device.In some instances, the needle becomes lodged in between the jaw and the slot of the blade making it impossible to unload.Marks on the cone of the needle can occur when pressure was applied on the toggle lever of the suturing device prior to closing the handles and prematurely attempting to toggle.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: ensure that the toggle levers are fully retracted prior to opening the jaws of the device.The reloading button should never be pressed when the instrument is in the body cavity, as this will release the needle.Inspect the application site to ensure hemostasis.Place additional sutures or use electrocautery if necessary to complete hemostasis.Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user or patient.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10618624
• MDR Text Key: 209550252
• Report Number: 9612501-2020-01406
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126753
• UDI-Public: 20884521126753
• Combination Product (y/n): N
• PMA/PMN Number: K934738
• 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: 11/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 170051
• Device Catalogue Number: 170051
• Device Lot Number: J9H0155Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other