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

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1223422-2023-00036
• Device Sequence Number: 12401959
• Product Code: GEI
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1002
• Device Catalogue Number: 1002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Seven-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male