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

Model Number 173016

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

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 nissen fundoplication, the surgeon stated that the jaws of the device would not open, finally the jaws opened, but the surgeon stated that there was an issue passing the needle and asked for a new device.The device was difficult to toggle.The surgeon removed the device from the patient and a new one and reload were opened.The scrub tech tried unloading the defective device but the needle would not release from the device.The scrub tech then tried using an instrument to remove the needle from the device but the needle broke off on the surgical table.The broken needle was found and disposed of.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted the instrument was returned with no blister package with exposed blades, and the right blade was partially bent.There were no other abnormalities that would have caused or contributed to the reported condition.After the blade had been bent back into position, the returned instrument was found to function properly and the test needle remained intact.No difficulty was experienced in loading, unloading or toggling the test needle in the returned instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.Additionally, the investigation detected a unreported condition of bent blade that has no relationship to the reported condition.The metal blades could have been bent/deformed during return shipping to the investigations laboratory as the device was not returned in appropriate blister package, return kit or with the metal blades retracted.Metal blades could also be bent during use where the device is subjected to excessive manipulation or an leveraging force.No further actions have been deemed necessary at this time.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: 9007955
• MDR Text Key: 183481885
• Report Number: 9612501-2019-01726
• 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
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J9F0866EY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1