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	Unspecified Kidney or Urinary Problem (4503)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The date of the sae onset was on (b)(6) 2023, but the site was aware of this event today (19jun2023), reporting this information to us early this morning.The reported sae was described as postoperative pelvic collection adjacent to rectum, anuria and pelvic hematoma which led to a prolonged hospitalization.The subject is a 71-year-old male patient.He presented with neoplasia of the lower rectum, so it was decided to undergo an ultra-low anterior resection of the rectum and a terminal colostomy on (b)(6) 2023.During the intervention, there was a complication due to ventilation and the surgery was converted into an open procedure.On (b)(6) 2023 the subject went to the emergency department for difficulty in urinating and discomfort in the hypogastrium.He also presented with fever.An abdominopelvic ct scan with iv contrast showed a poorly delimited liquid collection adjacent to the rectal stump and postoperative changes of vascular dissection of the ima.Treatment with piperacillin/tazobactam and urinary catheter.Rectal drainage of pelvic collection and hematoma.Admission to hospitalization with a diagnosis of post-surgical collection.
Additional Manufacturer Narrative
According to the investigator´s criteria, the sae has been determined to be related to the procedure (causal), but not related to the investigational device.

• 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: 17173142
• Report Number: 1223422-2023-00025
• Device Sequence Number: 7300011
• Product Code: GEI
• UDI-Device Identifier: 00811099010388
• UDI-Public: 00811099010388
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K013695
• 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): 06/20/2023

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): Five-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 06/21/2023
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male