MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCA 12F COMPLETE SET,EO

Model Number 44-2712

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Reference e-complaint- (b)(4).Investigation: x-initiated manufacturer's investigation.X-no sample returned.Analysis and findings: the reported complaint event cannot be verified or analyzed due to the absence of the affected inca device in that it was not returned.Should the affected device be returned in the future, the complaint may be reopened and amended as needed.A review of the two-year complaint history indicated that there were other similar complaints reported previously.Based on past similar reported event analysis investigations, it had been determined that the root cause was the incompatibility of the adapter used by the end user to mate or attach it to the csi white end connector.A review of the csi manufacturing assembly instructions indicated that nothing had been changed, and work instructions were properly being followed and adhered to.Further verification of sampled inventoried white adapter, part number 010-013, was performed in the way of a dimensional verification which found it to be within print tolerances.Correction and/or corrective action: none.Reason: corrective action is not applicable at this time due to the absence of the affected sample for investigative analysis.This complaint will be monitored for trending to access potential future action.Was the complaint confirmed? no.

Event Description

"the hose is disconnecting and coming off the plastic white piece.It will not stay connected." "patient is desat." ref e-complaint- (b)(4).

• Brand Name: INCA 12F COMPLETE SET,EO
• Type of Device: INCA
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: peter niziolek ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 8684289
• MDR Text Key: 148001818
• Report Number: 1216677-2018-00040
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

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
• Device Operator: No Information
• Device Expiration Date: 04/02/2021
• Device Model Number: 44-2712
• Device Catalogue Number: 44-2712
• Device Lot Number: 234438
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other