MAUDE Adverse Event Report: Rochal Technologies, LLC BIASURGE® Advanced Surgical Solution; Irrigation Solution

Model Number	BAS-0101
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2026, biasurge advanced surgical irrigation solution was used at the end of an abdominal procedure within the peritoneal cavity at (b)(6).The patient was an 18 year-old female with no known co-morbidities.The procedure was a revision of an anastomotic stricture from an appendectomy done one month prior to this case.The surgeon determined there was some abdominal contamination during the repair.At the completion of the robotic procedure, warmed biasurge was instilled into the abdominal cavity, and a small portion was not suctioned out of the cavity.The surgeon withdrew the instrumentation and went to proceed with the closure steps.Following the peritoneal cavity irrigation with biasurge the patient's blood pressure dropped requiring re-intubation and pressor support.The patient was checked for internal bleeding and none was found.After the case the patient was transferred to the icu intubated due to instability.There was no permanent injury to the patient.
Additional Manufacturer Narrative
An investigation was completed; based on the information documented in the batch record, the batch complies with product specifications and meets the requirements for final release.Based on the number of units distributed to date and the reported incidents, the estimated potential incident rate is (b)(4).Monitoring activities will continue to assess any emerging trends or additional reporting.

• Brand Name: BIASURGE® Advanced Surgical Solution
• Common Device Name: Irrigation Solution
• Manufacturer (Section D): Rochal Technologies, LLC; 12000 network blvd; suite b200; san antonio TX 78249
• Manufacturer (Section G): Rochal Technologies, LLC; 12000 network blvd; suite b200; san antonio TX 78249
• Manufacturer Contact: raza mohammed ; carretera a san isidro mazatepec 7000; tlajomulco de zuniga, jalisco 45640 ; MX 45640
• MDR Report Key: 50944875
• Report Number: 3021784063-2026-00002
• Device Sequence Number: 21445506
• Product Code: FRO
• UDI-Device Identifier: 00850017274006
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: BAS-0101
• Device Lot Number: Q2503011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 1 LB
• Patient Race: White