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 Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, on at laparoscopic liver lesion resection, the absorbable clip was used to ligate larger vessels with severed ends during the surgery.After using the ligation clip, it was found that the ligated blood vessel could not be properly clipped, and there was still active bleeding.The surgeon immediately used lines for ligation and then used the closing clip to close the blood vessel to ensure complete closure of the blood vessel.Due to the particularity of the surgery, if the incomplete clipping occurred after the surgery was completed.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12787960
• MDR Text Key: 280590921
• Report Number: 1219930-2021-04719
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057661
• UDI-Public: 10884521057661
• 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: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2021

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: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N9J0895Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/10/2021
• Date Device Manufactured: 09/25/2019
• 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: 53 YR
• Patient Sex: Male