MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN UNKNOWN LAPRO-CLIP INSTRUMENT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN LAPRO-CLIP INSTRUMENT

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

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 procedure, at the second firing, the external side of the clip didn't come out and the clip could not be closed.The procedure was completed with another device.The surgical time was extended by less than 30 min.There was no patient injury.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN LAPRO-CLIP INSTRUMENT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8552841
• MDR Text Key: 143707361
• Report Number: 1219930-2019-02614
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/29/2019

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
• Device Model Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Device Catalogue Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 09/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1