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

Model Number	1002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	02/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient suffered from severe dehydration from high ileostomy output.This is the most common complication following the creation of a new ileostomy.The device has no relation to this.
Event or Problem Description
The procedures performed on this subject were a robotic proctectomy, ileoanal reservoir and a protective ileostomy.As mentioned in my previous communication, the subject was previously diagnosed with ulcerative colitis.The techniques completed during the surgery are indicated below: trocar introduction.Release of mucosal fistula.Posterior and lateral mesorectal dissection with nerve preservation up to the pelvic floor.Anterior dissection of the rectum separating the rectovaginal septum up to the pelvic floor.Rectal section with two 60mm green robotic endo stapler loads.Release of small bowel mesentery root to duodenum.Section of terminal ileum with robotic endograpator.Extraction of the piece by pfannenstiel incision.Extracorporeal confection of ileoanal reservoir of about 13-14 cm (3 loads 60 mm beige signia).Reinforcement of the anterior face with loose vycril stitches.Mechanical circular rectal reservoir anastomosis 29 mm 4.8mm staple height.Anastomosis about 4-5 cm from anal margin.Loop ileostomy.Closure of incisions.20 days after the surgery, the subject goes to the hospital referring acute pain in the abdomen, with daily nausea and vomiting (usually at night).The subject has lost approximately 7 kilograms in two weeks, and she also referred asthenia and low arterial pressure (80/60mm hg).Liquid stool, with the emptiness of the reservoir every hour.No fever was reported.No other symptoms associated.The final diagnosis is "dehydration in subject porting a stoma.".

• Brand Name: M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL; 50 dunham rd suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL; 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: 16523406
• Report Number: 1223422-2022-00017
• Device Sequence Number: 16723474
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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: 03/02/2023
• Initial Report FDA Received Date: 03/10/2023
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female