MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD UNKNOWN ESTITCH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number UNKNOWN ESTITCH

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a laparoscopic appendectomy, the device did not activate, the stitching device jammed and another device was opened and used to complete the case.There was no patient injury.

• Brand Name: UNKNOWN ESTITCH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8710326
• MDR Text Key: 148407026
• Report Number: 9612501-2019-01183
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN ESTITCH
• Device Catalogue Number: UNKNOWN ESTITCH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/18/2019
• 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