MAUDE Adverse Event Report: MICROLINE SURGICAL INC M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENT

Model Number 1002

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

Patient Problem Fistula (1862)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

According to the investigator´s criteria, the sae has been determined to be related to the procedure (probable), but not related to the investigational device.

Event Description

The date of the sae onset was on (b)(6) 2023, reporting this information to us yesterday during the evening.The reported sae has been described as urethral fistula due to extreme proximity to the tumor which prolonged an existing hospitalization.The subject is a 83-year-old male patient.He presented a rectal neoplasia, so it was decided to undergo a robotic surgery, accompanied by an abdominoperineal amputation of rectum and intervention of miles on (b)(6) 2023.There is an incidental opening of the urethra during the procedure due to extreme proximity to the tumor.It is resolved with a suture during surgery.After the intervention, it is observed that the subject has abundant discharge of dirty fluid from the perineal wound, clinically the subject is fine.An attempt was made to place a urostomy bag in the wound in order to measure the volume of discharge, but without success.Due to the abundant discharge of dirty fluid from the perineal wound, it was decided to place two percutaneous nephrostomies (bilateral nephrostomy).This procedure will be performed during the next week.The event is considered "ongoing".

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Type of Device: MANUAL DETACHABLE SURGICAL INSTRUMENT
• Manufacturer (Section D): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer Contact: scott marchand davis ; 50 dunham rd suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 18141008
• MDR Text Key: 328179619
• Report Number: 1223422-2023-00036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K013696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1002
• Device Catalogue Number: 1002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male