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

Model Number 173016

Device Problems Component or Accessory Incompatibility (2897); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic procedure, the scrub tech was struggling with both the loading and unloading of the instrument in use.The doctor was also having difficulty using it and demonstrated how the instrument would not open fully within the patient after passing the needle, how the needle would stick within the tissue (jaws closed) as he was passing the needle.The doctor indicated that the experience with the instrument was similar to what had occurred with the previous 3 procedures.Opened another instrument to complete the procedure.

Event Description

According to the reporter, during a laparoscopic procedure, the scrub tech was struggling with both the loading and unloading of the instrument in use.The doctor was also having difficulty using it and demonstrated how the instrument would not open fully within the patient after passing the needle, how the needle would stick within the tissue (jaws closed) as he was passing the needle.Opened another instrument to complete the procedure.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Pmv found that device had a broken toggle switch component that came out of the device handle.Device was precluded from testing due to damaged toggle switch.Engineering disassembled the two devices and found that the chamfered short area of the wheel was broken; the center rod was slightly bent; and the flat pin was correctly oriented but bent.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of broken toggle wheel may occur when excessive force is applied to the device causing the toggle wheel to break and bending the center rod and flat pin.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: ENDO STITCH
• 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: 8276605
• MDR Text Key: 134062074
• Report Number: 9612501-2019-00150
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• 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,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8K0450EX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1