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

Model Number 170052

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

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 total laparoscopic hysterectomy procedure, while closing the vaginal cuff, half of the needle broke and fell into the patient's cavity.It was also reported that the needle was retrieved.The instrument was reloaded and the procedure was completed without issue.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 that the broken needle was returned loaded in a device.The needle was removed from device for further inspection.The needle was inspected under a microscope and no other abnormality besides the needle being broken was observed and no suture was present with needle.Functional evaluation could not be performed as the needle was broken.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 the bent or broken needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.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: 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: 9712293
• MDR Text Key: 179758299
• Report Number: 9612501-2020-00275
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521126746
• UDI-Public: 20884521126746
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170052
• Device Catalogue Number: 170052
• Device Lot Number: J9F0686Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1