MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176615

Device Problems Mechanics Altered (2984); Physical Resistance/Sticking (4012)

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

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, after the clip was clamped during a laparoscopic left hepatobiliary tumor resection, the handle could not rebound and could not continue to be clamped.The device was immediately replaced.It was stated that there was an increasing amount of bleeding and increasing surgery time.It was also stated that there was an unsafe risk to the patient.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9078364
• MDR Text Key: 158867890
• Report Number: 9612501-2019-01761
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057807
• UDI-Public: 10884521057807
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 176615
• Device Catalogue Number: 176615
• Device Lot Number: J9D2329NY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Date Device Manufactured: 04/24/2019
• 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): Other
• Patient Age: 28 YR