MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number SMM-5831

Device Problems Dull, Blunt (2407); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Embedded In Tissue or Plaque (3165); Unintended Radiation Exposure (4565)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during thoracoscopic bullectomy, at closure of trocar wound, the needle became dull while stitching several times, so usage was discontinued.A suture from another lot was used to resolve the issue in order to complete the case.The tip was suspected to have remained inside the body so x-ray imaging was performed, but it could not be found.

• Brand Name: MAXON
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• 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: 12979947
• MDR Text Key: 282092806
• Report Number: 9612501-2021-02060
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10884523004885
• UDI-Public: 10884523004885
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

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: SMM-5831
• Device Catalogue Number: SMM-5831
• Device Lot Number: D0K2875FY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/10/2021
• Date Device Manufactured: 10/29/2020
• 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