MAUDE Adverse Event Report: COOPERSURGICAL, INC. KOH-EFFICIENT,RUMI,4.0CM

Model Number	KC-RUMI-40
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical , inc.Is currently investigating the reported condition.
Event or Problem Description
Report submitted by csi (b)(4) on behalf of end-user- doctor (b)(6) (report from (b)(6)).Incident detail - "vaginal laceration was occurred during use of koh-efficient 4.0cm." patient injured.Reportable based on japanese regulation.Medical intervention -hemostatic suture on corresponded wound.Additional info stated "the incident might be caused by misreading the scale of kc sizer.Therefore, the doctor chose wrong (bigger) size of koh-efficient." koh-efficient rumii 4-0cm kc-rumi-40.E-complaint- (b)(4).
Additional 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 12/01/20 under work order (b)(4).Manufacturing record review dhr - 296549 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 record not applicable to this product.Historical complaint review.A review of the 2-year complaint history did not show similar reported complaint condition.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Functional evaluation.Evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.Root cause root cause is not applicable for this complaint as indicated in the complaint, the wrong size product was used for the operation, indicating a usage error.Per the information given in the complaint, the was no product malfunction attributable to any manufacturing issue.The complaint will not be confirmed on the basis that the kc-rumi product did not fail.*correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the product did not malfunction no further training required at this time.*was the complaint confirmed? no.
Event or Problem Description
Report submitted by csi japan on behalf of end-user-(report from amco co.Ltd.) "vaginal laceration was occurred during use of koh-efficient 4.0cm." patient injured.Reportable based on japanese regulation.Medical intervention -hemostatic suture on corresponded wound.Additional info stated "the incident might be caused by misreading the scale of kc sizer.Therefore, the doctor chose wrong (bigger) size of koh-efficient." koh-efficient rumi 4 cm kc-rumi-40 e-complaint (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,4.0CM
• Common Device Name: KOH-EFFICIENT,RUMI,4.0CM
• 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: 12009544
• Report Number: 1216677-2021-00128
• Device Sequence Number: 4052323
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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 Expiration Date: 12/01/2023
• Device Model Number: KC-RUMI-40
• Device Catalogue Number: KC-RUMI-40
• Device Lot Number: 296549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: Required Intervention; Other
• Patient Sex: Unknown