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

Model Number UNKNOWN ENDO CLIP APPLIER

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Chest Pain (1776); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: the extraordinary journey of a metal endoclip to the outside of the chest wall source european journal of cardio-thoracic surgery, volume 56, 2019 (208-209) date of publication:1 october 2018.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to the literature, the patient underwent bilateral sympathetic blockage via thoracoscopic surgery for treatment of cyanosis and swelling due to raynaud's disease.On the fourth day, one of the clip was found to have fallen in the pleural cavity in the right hemothorax.The patient was discharged after being checked and was asymptomatic with no other intervention.Five years, after the procedure, the patient was admitted due to right side chest pain.Chest x-ray and computed tomography scan was done and metallic density on the extrathoracic of the 7th rib was observed.The patient underwent fluoroscopy under local anesthesia and the clip was detected and located at the subcutaneous space and was extracted.

• Brand Name: UNKNOWN ENDO CLIP APPLIER
• 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: 9175280
• MDR Text Key: 161832484
• Report Number: 9612501-2019-01941
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ENDO CLIP APPLIER
• Device Catalogue Number: UNKNOWN ENDO CLIP APPLIER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• 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: 48 YR