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

Model Number SMBTTRND

Device Problems Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)

Patient Problem No Code Available (3191)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, in the beginning of the procedure during a totally extraperitoneal repair, when trocar had been placed in the pre-peritoneal space nothing happened when insufflation of gas was done.The surgeon used another trocar and when the gas was insufflated in the pre-peritoneal space a plastic ring was found.The issue was resolved by removing the plastic ring and the surgical time was extended more than 30 minutes due to the event.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted: the valve seal was disengaged.The trocar balloon, dissector balloon, lock collar and obturator appeared intact.The insufflation bulb and inflation syringe were received.A functional evaluation found that the dissector balloon and trocar balloon were inflated, no leaks detected.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.An insufficient amount of adhesive silicone was applied which resulted in the lack of adherence of the seal.A process improvement has been initiated to prevent this condition from recurring.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPACEMAKER PLUS
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9321914
• MDR Text Key: 166362140
• Report Number: 2647580-2019-05632
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521067578
• UDI-Public: 10884521067578
• Combination Product (y/n): N
• PMA/PMN Number: K042412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: SMBTTRND
• Device Catalogue Number: SMBTTRND
• Device Lot Number: P8L1528Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR