MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOCK; CLIP, IMPLANTABLE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

The tip of the clip applier broke into patient and could not be found during the surgical procedure.The surgeon and the team tried looking for it with the robot camera and to no avail.X-ray was taken after the ileal conduit was created and closure since surgeon said its insignificant and they are not going to go back in.The result is positive.The patient was transferred to pacu stable.

• Brand Name: HEMOLOCK
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 10808635
• MDR Text Key: 215314643
• Report Number: 10808635
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 79