MAUDE Adverse Event Report: COVIDIEN LLC ENDO PADDLE RETRACT; RETRACTOR

Model Number 173046

Device Problems Mechanical Problem (1384); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Event Description

Upon closing the endo paddle retractor during a laparoscopic right adrenalectomy, the frame of the paddle did not close completely such that when retracting the paddle the plastic sheath tore.It was impossible to get the instrument into and out of the port.With force (without patient harm) we were able to remove the paddle.

• Brand Name: ENDO PADDLE RETRACT
• Type of Device: RETRACTOR
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7536497
• MDR Text Key: 109039372
• Report Number: 7536497
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 173046
• Device Lot Number: P8B0747X
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR