MAUDE Adverse Event Report: COOPERSURGICAL, INC. STERILE 3.5 ULTEM KOH-EFF

Model Number AD750-KE35

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report submitted by csi rep- incident report: manipulator break during a tlh ,nobody was injured and the case finished successfully.Additional info- incident details surrounding event robot tlh, patient's anatomy was average and the case wasn't difficult or long.The sliding mechanism on the manipulator split in half when manipulating.The colpotomy had begun, and the first assist manually held the manipulator together until it was over.Once the fa laid the broken manipulator on the mayo stand, i was able to see the only thing holding it together was the occluder ballon.Did the incident occur before, during, or after a procedure? during patient/gamete/embryo status.No injuries.Isolated event.Ref e-complaint-(b)(4).Sterile 3.5 ultem koh-eff ad750-ke35 e-complaint-(b)(4).

Manufacturer Narrative

Investigation x-initiated manufacturer's investigation x-review dhr x-inspect returned samples *analysis and findings e-complaint-(b)(4).*was the complaint confirmed? yes distribution history the complaint product was manufactured at csi on 04/17/20 under work order 287996.Manuf.Record review dhr - 287996 was reviewed and was found to have non-conformity.The work order was reworked and subsequently resubmitted for qc inspection and passed.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 show other similar reported complaint conditions.Product receipt the product was received via rma (b)(4).Visual eval.Evaluation of the complaint product revealed that the slider half were separated.This indicates that the slider halves may not have had enough glue applied to the joints during assembly.Functional evaluation evaluation of the complaint product revealed that the product was not working as intended.The slider halves were separated.Root cause the root cause of this issue has been attributed to the lack of, or not enough glue being applied to the slider halves.The process for glue application is manually performed, and during this step of the manufacturing step, it is possible that not enough glue was applied to the posts prior to pressing them together.Currently, each lot of ad750 is sampled through an established aql sample size, and is tested for slider half separation.During the qc testing of the reworked lot, no non-conformances were found.The slider half does not appear to have been a systemic issue.*correction and/or corrective action new capital expenditure authorization submitted (cea-2020-09-002) to develop and implement a new mold that will allow for the parts to be ultrasonically welded together.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report submitted by csi rep- incident report: manipulator break during a tlh ,nobody was injured and the case finished successfully.Additional info- incident details surrounding event robot tlh, patient's anatomy was average and the case wasn't difficult or long.The sliding mechanism on the manipulator split in half when manipulating.The colpotomy had begun, and the first assist manually held the manipulator together until it was over.Once the fa laid the broken manipulator on the mayo stand, i was able to see the only thing holding it together was the occluder ballon.Did the incident occur before, during, or after a procedure? during patient/gamete/embryo status no injuries isolated event.Ref e-complaint- (b)(4).(b)(4).Sterile 3.5 ultem koh-eff ad750-ke35 e-complaint-(b)(4).

• Brand Name: STERILE 3.5 ULTEM KOH-EFF
• Type of Device: STERILE 3.5 ULTEM KOH-EFF
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10694832
• MDR Text Key: 219326116
• Report Number: 1216677-2020-00235
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750-KE35
• Device Catalogue Number: AD750-KE35
• Device Lot Number: 287996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• 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