MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,ARCH,3.0CM

Model Number KC-ARCH-30

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/06/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the condition reported.

Event Description

Fda mw5104616.Event description: koh ring came off of the device during the procedure.This is something that should not happen.This is the second time this has happened.Koh-efficient arch 3-0cm kc-arch-30 e-complaint- (b)(4).

Event Description

Fda mw5104616.B5 event description: koh ring came off of the device during the procedure.This is something that should not happen.This is the second time this has happened.Koh-efficient arch 3cm kc-arch-30 (b)(4).

Manufacturer Narrative

Investigation initiated manufacturer's investigation no sample returned.Review dhr *analysis and findings distribution history the complaint product was manufactured at csi on 03/29/21 under work order (b)(4).Manufacturing record review.Dhr - 301193 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.Serv.History record service history record not applicable to this product.Hist.Complaint review.A review of the 2-year complaint history did show similar reported complaint condition.Product recpt the complaint product has not been returned to coopersurgical.Visual eval evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional eval evaluation of the complaint product could not be completed as the complaint product was not been returned to coopersurgical.However, the complaint condition is very similar to other complaints as mentioned earlier.Root cause no definitive root cause for this issue could be reliably determined at this time, with the information provided in the complaint.Complaint product was not returned for investigation.To mitigate cup detachment, csi stafford has implemented 100% in process inspection of the product via bend test, followed by an aql qc inspection requiring the units also pass bend/pull test.Corrective actions coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the root cause cannot be reliably determined with the information provided.No further training required at this time.*was the complaint confirmed? no.

• Brand Name: KOH-EFFICIENT,ARCH,3.0CM
• Type of Device: KOH-EFFICIENT,ARCH,3.0CM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12818527
• MDR Text Key: 281922504
• Report Number: 1216677-2021-00262
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KC-ARCH-30
• Device Catalogue Number: KC-ARCH-30
• Device Lot Number: 301193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other