MAUDE Adverse Event Report: COVIDIEN SPACEMAKER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SMSBTOVLX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: smsbtovlx, sm pro smsbtovlx access dissector system, (lot # p4k1348) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic repair of bilateral inguinal hernias, the device was advanced into the peritoneum while being inserted into the extra-peritoneal space, which led to a change in surgical technique from totally extraperitoneal (tep) to transabdominal preperitoneal (tapp) repair.The surgery was extended by 15-20 minutes but was able to remain laparoscopic.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: d4 (udi#), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.During evaluation, rpa performed functional testing; the hole was covered and dissector balloon was inflated using a test insufflation bulb, no leaks detected however an odd shape was noted.The trocar balloon was attempted to be inflated using a test inflation syringe, however a hole was noted.It was reported that there was medical complication.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of hole in the balloon.The product analysis noted evidence that the device was not used as intended.This issue may occur when care is not exercised during clinical application.Another unreported condition was identified: balloon with irregular shape.The product analysis noted evidence that the device was not used as intended.This issue when positioning the device during its inflation deployment or deflation process, or its tissue planes process, during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: balloon products must be treated with care.Damage to balloons from instruments during the procedure may cause product failure.Once the extraperitoneal space is adequately dissected, deflate the dissection balloon by removing the endoscope or by removing the inflation bulb from the dissector.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SPACEMAKER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22746029
• Report Number: 2647580-2025-02483
• Device Sequence Number: 4488909
• Product Code: GCJ
• UDI-Device Identifier: 10884521545311
• UDI-Public: (01)10884521545311(17)260930(10)P4K1348(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: SMSBTOVLX
• Device Catalogue Number: SMSBTOVLX
• Device Lot Number: P4K1348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Male