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

Model Number UNKNOWN LAPROCL INS

Device Problems Device Slipped (1584); Malposition of Device (2616); Device Fell (4014); Separation Problem (4043)

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

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: health professional (hpro).(b)(4).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

(b)(4).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 cholangio-pancreatography(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; ct 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; ct 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7710145
• MDR Text Key: 114694965
• Report Number: 1219930-2018-03980
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LAPROCL INS
• Device Catalogue Number: UNKNOWN LAPROCL INS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/07/2018; 10/02/2018; 10/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization