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

Model Number 170053

Device Problems Entrapment of Device (1212); Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/31/2022

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 bariatric roux-en-y gastric bypass, during the oversewing of the gastrojejunostomy anastomosis, on the first reload, the needle of the endo stitch suture became stuck in the receiving end jaws of the handle and was caught with the tissue. the needle did not penetrate the tissue completely, but both the needle and tissue were being held in the receiving end of the jaws.The jaws were able to open completely.  the metal bars on the jaws was not present.The surgeons had to twist, turn and tug at the reload before it would come away from the tissue.The second suture that was used got stuck also.The attending surgeon, was able to free the needle from the stomach tissue and completed the oversewing without issue.It was noted that the patient had some serosal tearing due.

Manufacturer Narrative

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.

Event Description

According to the reporter, during a laparoscopic bariatric roux-en-y gastric bypass, during the oversewing of the gastrojejunostomy anastomosis, on the first reload, the needle of the endo stitch suture became stuck in the receiving end jaws of the handle and was caught with the tissue. the needle did not penetrate the tissue completely, but both the needle and tissue were being held in the receiving end of the jaws.The jaws were able to open completely by using pressure and toggling to release the reload.  the metal bars on the jaws was not present.The surgeons had to twist, turn and tug at the reload before it would come away from the tissue.The second suture that was used got stuck also.The attending surgeon, was able to free the needle from the stomach tissue and completed the oversewing without issue.It was noted that the patient had some serosal tearing.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted a misloading witness marks were noted on the loading slot of the needle.Microscopic inspection noted flat pin marks on the needle cones.It was reported that the jaws of the device remain closed on tissue and the suture was too tight.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when pressure is applied on the toggle lever of the suturing device prior to closing the handles and prematurely attempting to toggle.While the improperly loaded needle can occur if either the endo stitch dlu has incorrect orientation or the endo stitch suturing device is held with the printed information facing down when the needle is 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.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 and/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 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 14698658
• MDR Text Key: 294058000
• Report Number: 9612501-2022-00971
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126739
• UDI-Public: 20884521126739
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170053
• Device Catalogue Number: 170053
• Device Lot Number: J1J2162Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other