MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EXTRA VIEW; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	OMS-XB1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
According to the reporter, intra-operatively of a laparoscopic totally extraperitoneal hernia repair, while in the extraperitoneal space, the balloon popped while being inflated.The case was continued.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Three devices were received for evaluation.Two were opened by the account with the appropriate packaging.One was sealed with the appropriate.Visual inspection noted visual inspection of the sealed device noted that the packpackagingaging was opened and the balloon, obturator, converter doors, main valve seal and insufflation bulb was intact.Visual inspection of the opened devices noted that the balloons were broken at the distal end.The main valve seals and converter doors were intact.The insufflation bulbs were not received.The obturators were received.Functional testing of the sealed device found, when using the returned insufflation bulb, the balloon was inflated, it was properly formed and no leaks detected.The converter doors moved and locked in place properly.Functional testing of the opened devices found that the balloons could not be inflated due to the hole at the distal end.The converter doors move freely and were secured in place.It was reported that the balloon was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when contact is made with a sharp surgical instrument during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.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.
Additional Manufacturer Narrative
Additional information: g3 correction: h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.Three devices were received for evaluation.Two were opened by the account with the appropriate packaging.One was sealed with the appropriate packaging.Visual inspection of the sealed device noted that the packaging was opened and the balloon, obturator, converter doors, main valve seal, and insufflation bulb were intact.Visual inspection of the opened devices noted that the balloons were broken at the distal end.The main valve seals and converter doors were intact.The insufflation bulbs were not received.The obturators were received.Functional testing of the sealed device found, when using the returned insufflation bulb, the balloon was inflated, it was properly formed and no leaks detected.The converter doors moved and locked in place properly.Functional testing of the opened devices found that the balloons could not be inflated due to the hole at the distal end.The converter doors move freely and were secured in place.It was reported that the balloon was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when contact is made with a sharp surgical instrument during clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.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: EXTRA VIEW
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19979912
• Report Number: 2647580-2024-03593
• Device Sequence Number: 8374932
• Product Code: GCJ
• UDI-Device Identifier: 10884521068025
• UDI-Public: 10884521068025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954175
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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 Model Number: OMS-XB1
• Device Catalogue Number: OMS-XB1
• Device Lot Number: P3L0712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 10/10/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/10/2024; 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown