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

Model Number 8886848813

Device Problems Leak/Splash (1354); Device Slipped (1584); Malposition of Device (2616); Device Fell (4014)

Patient Problems Abdominal Pain (1685); Inflammation (1932); No Code Available (3191)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: health professional (hrpo).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, there was an abdominal pain on the fourth day following a laparoscopic cholecystectomy.The diagnosis of complications such as inflammation around the bile duct and bile leakage were found through a doppler ultrasound.It was believed that the clip clamped at the bile duct was displaced and the blood vessel clip had fallen off.This resulted to a month long hospitalization.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, there was an abdominal pain on the fourth day following a laparoscopic cholecystectomy.The diagnosis of complications such as inflammation around the bile duct and bile leakage were found through a doppler ultrasound.It was believed that the clip clamped at the bile duct was displaced and the blood vessel clip had fallen off.Additional operation was performed, drain bile, and empyema by percutaneous drainage, removed calculus from the bile duct by endoscopic retrograde cholangiopancreatography (ercp).There was no permanent tissue damage.This resulted to a month long hospitalization.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAPRO-CLIP
• 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: 7710278
• MDR Text Key: 114705280
• Report Number: 1219930-2018-03985
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521057668
• UDI-Public: 20884521057668
• Combination Product (y/n): N
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N7H1179X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization