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

Model Number 8886848813

Device Problem Device Slipped (1584)

Patient Problems Hemostasis (1895); Blood Loss (2597); No Code Available (3191)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, biological clip has been applied successfully on a laparoscopic right colon resection when absorbable clip slid when dealing with accompanying veins and arteries started bleeding.This resulted to an extended cut to more than one inch and an extended operating time.The patient had an emergency hemostasis and was transferred to laparotomy was done to complete the case.

• 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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7452791
• MDR Text Key: 106244764
• Report Number: 1219930-2018-02216
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521057668
• UDI-Public: 20884521057668
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K925602
• 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
• Report Date: 04/23/2018

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 Expiration Date: 10/31/2022
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N7K0193X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/23/2018
• Date Device Manufactured: 10/05/2017
• 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): Required Intervention
• Patient Age: 71 YR