MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI- HARRIS UTERINE MANI

Model Number 6001

Device Problem Break (1069)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Incident details surrounding event (b)(6) 2022 laparoscopic bso on 39yof per surgeon & surgical tech, "tip of manipulator broke off inside patient's uterus during procedure.Normal use caused tip to snap." no patient complications were endured.Created 10 minute delay.1216677-2022-00091 humi- harris uterine mani 6001 e-complaint-(b)(4).

Manufacturer Narrative

The reported condition is currenlty being investigated.

Manufacturer Narrative

Investigation.No sample returned review dhr.Analysis and findings complaint (b)(4).Distribution history: this complaint unit was manufactured at csi on 06/12/2019 under wo # (b)(4) and shipped on 06/28/2019.Manufacturing record review: dhr-258143 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: iqc-52859 lot numbers m18394 and m18875 were reviewed and no non-conformities, related to the complaint condition, were noted.Service history record: service history not applicable for 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.If the product should returned at a later date, it will be evaluated, and any findings will be appended to this investigation.There was no inventory of lot number 258143 to test.Root cause: there was no product returned for evaluation.If further information becomes available at a later date this investigation will be amended accordingly.Definitive root cause is indeterminable.Corrective actions.Coopersurgical will continue to monitor this complaint condition for trends.No further training required at this time.*was the complaint confirmed? no.

Event Description

Incident details surrounding event.(b)(6) 2022 laparoscopic bso on 39yof.Per surgeon & surgical tech, "tip of manipulator broke off inside patient's uterus during procedure.Normal use caused tip to snap.".No patient complications were endured.Created 10 minute delay.Did the incident occur before, during, or after a procedure? during patient, gamete, embryo, or end user involvement? yes.Any patient injury or impact to the gamete or embryo? no.Medical or procedural intervention? no.Patient/gamete/embryo status stable.1216677-2022-00091-1 humi- harris uterine mani 6001 e-complaint-(b)(4).

• Brand Name: HUMI- HARRIS UTERINE MANI
• Type of Device: HUMI- HARRIS UTERINE MANI
• 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: 13860172
• MDR Text Key: 295809703
• Report Number: 1216677-2022-00091
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K770727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: 258143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2019
• 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