MAUDE Adverse Event Report: SYNAPTIVE MEDICAL INC. SYNAPTIVE TRACKABLE SUCTION; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	SYN-0653
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause is unknown at the time of reporting although can be attributed to laser etching on the tubes.Multiple complaints were reported from the same site.Issue is easily detectable prior to use and labeling instructions advise user of the following: "the trackable suction tubes are semi-disposable and end of life is determined by wear, damage and corrosion experienced during use.Always inspect suction components prior to use and replace if worn or damaged." note: all affected serial numbers and udis have not been included in this report due to space constraints.
Event or Problem Description
Trackable suction tube exhibiting signs of corrosion at locations where it had been etched.Issue was detected by synaptive representative prior to surgery.No patient involvement.

• Brand Name: SYNAPTIVE TRACKABLE SUCTION
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): SYNAPTIVE MEDICAL INC.; 555 richmond street w.; suite 800; toronto, on M5V 3 B1; CA M5V 3B1
• MDR Report Key: 10658786
• Report Number: 3012075008-2020-00008
• Device Sequence Number: 3564395
• Product Code: GCX
• UDI-Device Identifier: 00670082000214
• UDI-Public: (01)00670082000214(11)200317(10)0653AP15C17,(01)0067008200022(11)200212(10)0654AP14S43,(01)00670082000238(11)200203(10)0655AP14S44
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: No Information
• Device Model Number: SYN-0653
• Device Catalogue Number: SYN-0657, SYN-0783
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1