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

Model Number KC-RUMI-40

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currently investigating the reported condition.

Event 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).

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 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
• Type of Device: 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
• MDR Text Key: 263374668
• Report Number: 1216677-2021-00128
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937015089
• UDI-Public: 888937015089
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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): Required Intervention; Other