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

Model Number	KC-ARCH-30
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by csi rep.Incident report -occluder balloon popped.Patient injury - laceration.Ref e-complaint-(b)(4).Koh-efficient rumi 3-0cm kc-rumi-30 e-complaint-(b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation, no sample returned, review dhr.*analysis and findings, distribution history a distribution history record review was not possible for this product as the product lot number was not provided for investigation manufacturing record review a dhr review was not possible as a lot number was not provided.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history record not applicable to this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.There were no prior complaint history where the product had caused a laceration due to the occluder popping.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 evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause no definitive root cause for this issue could be reliably determined at this time, as the product was not returned for evaluation, nor information such as the lot number was provided.It should be noted that the dfu of the device (rumiiikoh-dfu) states that the device should be tested by inflation of the occluder with 20-60cc of saline prior to usage.The complaint indicates that the device was in use, and appears to have been working prior to the failure.The amount of saline to be inflated is 60cc t0 120cc as mentioned in the dfu.A possible root cause of the failure may be that the occluder was over-inflated, or encountered a sharp object during usage.The complaint condition of a popped occluder leading to a laceration does not show up in the complaint history, and is an isolated event.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.*was the complaint confirmed? no.
Event or Problem Description
Occluder balloon popped.Patient injury - laceration.Koh-efficient rumi 3-0cm kc-rumi-30 (b)(4).

• Brand Name: KOH-EFFICIENT,ARCH,3.0CM
• Common Device Name: 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: 10660147
• Report Number: 1216677-2020-00233
• Device Sequence Number: 16937459
• Product Code: HEW
• UDI-Device Identifier: 00888937015072
• UDI-Public: 888937015072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: Health Professional
• Device Model Number: KC-ARCH-30
• Device Catalogue Number: KC-ARCH-30
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/22/2020
• Initial Report FDA Received Date: 10/11/2020
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown