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

Model Number KC-RUMI-40

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical , inc.Is currenlty investigating the condition reported.

Event Description

Complaint information provided by csi sales- incident details- end of instrument that is supposed to be welded together broke off inside patient." rumi ii koh-efficient 4.0 ref: (b)(4).Lot 312201 1216677-2022-00106 koh-efficient rumi 4-0cm kc-rumi-40 e-complaint-(b)(4).

Event Description

Complaint information provided by csi sales.Incident details: end of instrument that is supposed to be welded together broke off inside patient." rumi ii koh-efficient 4.0.Ref: kc-rumi-40.Lot: 312201.1216677-2022-00106 koh-efficient rumi 4-0cm kc-rumi-40 (b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.Analysis and findings: distribution history: the complaint product was manufactured at csi on 11/17/2021 under work order: (b)(4).Manufacturing record review: dhr - 312201 was reviewed and no non-conformity, 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 conditions.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.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint was not confirmed.Preventative action activity : coopersurgical will continue to monitor this complaint condition for trends.

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned, x-review dhr.*analysis and findings: distribution history: the complaint product was manufactured at csi on 11/17/2021 under work order (b)(4).Manufacturing record review: dhr - 312201 was reviewed and no non-conformity, 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 conditions.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.*correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint was not confirmed.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Complaint information provided by csi sales- incident details- end of instrument that is supposed to be welded together broke off inside patient." rumi ii koh-efficient 4.0, ref: kc-rumi-40, lot 312201.1216677-2022-00106 koh-efficient rumi 4-0cm kc-rumi-40 (b)(4).

• Brand Name: KOH-EFFICIENT,RUMI,4.0CM
• Type of Device: KOH-EFFICIENT,RUMI,4.0CM
• 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 drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 14073873
• MDR Text Key: 295809554
• Report Number: 1216677-2022-00106
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: KC-RUMI-40
• Device Catalogue Number: KC-RUMI-40
• Device Lot Number: 312201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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