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

Model Number UNKNOWN ENDO CLIP APPLIER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2019

Event Type  Death  

Event Description

According to the reporter, the patient died.It was reported that the small titanium clip was delivered to the esophagus.

Manufacturer Narrative

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

• 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 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13548811
• MDR Text Key: 285739160
• Report Number: 9612501-2022-00233
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• 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): Death