MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 4.0 SOFT KOH-EFF

Model Number AD750SC-KE40

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported complaint condition.

Event Description

Report submitted by csi rep - stated "handle split in 2 during manipulation "."in the middle of the case, the handle split in two at the middle point of gluing".Ref e-complaint: (b)(4).1216677-2020-00145 sterile 4.0 ultem koh-eff ad750-ke40 e-complaint: (b)(4).

Event Description

Report submitted by csi rep - stated "handle split in 2 during manipulation "."in the middle of the case, the handle split in two at the middle point of gluing".Ref (b)(4).1216677-2020-00145 sterile 4.0 ultem koh-eff ad750-ke40 (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 03/03/20 under work order 286806.Manuf.Record review: dhr - 286806 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 hist.Record : service history record not applicable to this product.Historical complaint review: a review of the 2-year complaint history did not showed similar reported complaint conditions.Product receipt: 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.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: the root cause of this issue cannot be reliably determined based on the information provided.The product was discarded and was not available for root cause analysis.Was the complaint confirmed? no.Correction and/or corrective action : none.Reason: no further training required at this time.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

• Brand Name: STERILE 4.0 SOFT KOH-EFF
• Type of Device: STERILE 4.0 SOFT KOH-EFF
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 10278048
• MDR Text Key: 200613303
• Report Number: 1216677-2020-00145
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K180429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AD750SC-KE40
• Device Catalogue Number: AD750SC-KE40
• Device Lot Number: 286806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other