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

Model Number 44-2715

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow up report will be filed.(b)(4).

Event Description

Internal diameter of white adaptors not fitting snug to vent circuits as before.(b)(4).

Event Description

Internal diameter of white adaptors not fitting snug to vent circuits as before.Ref (b)(4).

Manufacturer Narrative

Reference (b)(4).Investigation: x-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings: distribution history.The complaint product was manufactured at csi on 7/19/2019 under work order 234439.Manufacturing record review: dhr-44-2712-234439 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record.Service history not applicable for this product.Historical complaint review: a review of the attached 2-year complaint history showed similar reported complaint conditions.All similar reported complaints for which product was returned were attributed to use of incompatible, non-coopersurgical connectors.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: INCA 12F COMPLETE SET,EO
• Type of Device: INCA
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct CT 06611
• MDR Report Key: 8949181
• MDR Text Key: 156450393
• Report Number: 1216677-2019-00242
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K911780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

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
• Device Operator: No Information
• Device Expiration Date: 04/16/2021
• Device Model Number: 44-2715
• Device Catalogue Number: 44-2715
• Device Lot Number: 234439
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other