MAUDE Adverse Event Report: COOPERSURGICAL, INC. CODAAIR 800,24V UNIVRS.AD

Model Number A800-008

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported conditon.

Event Description

Ref : e-complaint-(b)(4).Report submitted by (b)(6)- incident report stated: from - (b)(6): "we send a coda unit to customer.And he reports that when he connected he power cable the connection moved inside the unit, he powered on the unit and works, but then he disconnect to move the unit to another place in lab and when he tried to disconnect he said that he saw a sparks and the light in the lab got turned off (because electrical protection).1216677-2020-00251 codaair 800 24v univrs ad a800-008 e-complaint-(b)(4).Follow-up initiated for additional information on impact of reported condition.10.02.2020- update of follow-up as follows: *was there any patient involvement? ·[?] no, the coda items are never in direct contact with the patient.They are air purifiers.*any injury or adverse event related to the reported condition? ·[?] no, the coda items are never in direct contact with the patient.They are air purifiers.*was there any additional medical attention need as result of reported condition? ·[?] no, the coda items are never in direct contact with the patient.They are air purifiers.*how was situation remedy? ·[?]the coda item was not connected so it is not active now.

Manufacturer Narrative

Investigation x-no sample returned *analysis and findings complaint (b)(4).Was the complaint confirmed? no distribution history: this complaint unit was manufactured at csi on 9/11/2019 under wo (b)(4) and shipped on 2/28/2020.Manufacturing record review: dhr 273699 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: no additional service history records found for this unit.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint unit was not possible as no unit was returned.Functional evaluation: a functional evaluation of the unit was not possible as no unit was returned.Root cause: a review of the component suggests the unit would have to have been notably damaged with significant force to have the receptacle recess inward.However, no definitive root cause for this issue could be reliably determined at this time.Correction and/or corrective action an attempt to confirm the unit will be returned has not culminated in a return.Should the unit be returned the complaint will be updated accordingly.No further corrective action is necessary.No further training required at this time.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Ref : (b)(4).Report submitted by kathy miners- incident report stated- from - geraldo sanchez (lepsi) "we send a coda unit to customer.And he reports that when he connected he power cable the connection moved inside the unit, he powered on the unit and works, but then he disconnect to move the unit to another place in lab and when he tried to disconnect he said that he saw a sparks and the light in the lab got turned off(because electrical protection) 1216677-2020-00251 codaair 800 24v univrs ad a800-008 (b)(4).Follow-up initiated for additional information on impact of reported condition.10.02.2020- update of follow-up as follows: was there any patient involvement? no, the coda items are never in direct contact with the patient.They are air purifiers.Any injury or adverse event related to the reported condition? ·no, the coda items are never in direct contact with the patient.They are air purifiers.Was there any additional medical attention need as result of reported condition? · no, the coda items are never in direct contact with the patient.They are air purifiers.How was situation remedy? ·[?]the coda item was not connected so it is not active now.

• Brand Name: CODAAIR 800,24V UNIVRS.AD
• Type of Device: CODAAIR 800,24V UNIVRS.AD
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10770159
• MDR Text Key: 249824857
• Report Number: 1216677-2020-00251
• Device Sequence Number: 1
• Product Code: MQG
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K001486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A800-008
• Device Catalogue Number: A800-008
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other