MAUDE Adverse Event Report: COOPERSURGICAL, INC. 3704

Model Number 3704

Device Problem Material Integrity Problem (2978)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

Complaint information provided by csi sales- there is a dr.Who is concerned about occasional trauma from lonestar hooks.He worries about patient tearing.After the procedure, the patient was bleeding when hooks were removed.The dr, applied pressure with gauze to stop the bleeding which to my observation took a while.1216677-2022-00119 lonestar hooks e-complaint-(b)(4).

Manufacturer Narrative

The reported condition is currently being investigated.

Event Description

Update as per complaint intake form.Incident details surrounding event.The dr.Who is concerned about occasional trauma from lonestar hooks.He worries about patient tearing.After the procedure, the patient was bleeding when hooks were removed.The dr.Applied pressure with gauze to stop the bleeding which to my observation took a while.And now the doctor is afraid to use the product again due to that incident.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? yes.Medical or procedural intervention? yes.Patient/gamete/embryo status.Patient tearing during procedure and discomfort after procedure due to tearing when patient became conscious.Ref: 1216677-2022-00119 gynecology kit box of 5 - 3704 - e-complaint-(b)(4).

Manufacturer Narrative

The reported condition is currently being investigated.

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation: x-no sample returned.X-review dhr.Analysis and findings: complaint: (b)(4) - 3704 mdr - reportable - patient bleed after removal of stay distr.History.The complaint product was manufactured at csi on 10/19/2020 under work order (b)(4).Manuf.Record review dhr 295175 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspect.Review: incoming inspection record review not applicable to this product.Serv.Hist.Record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show any similar reported complaint conditions.There have been no complaints on this product in the previous two years.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 was not returned to coopersurgical functional eval.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.The stays are made with hooks at the end to serve as a way to retract tissue during use.It is unknown how the product was used during the retraction of the tissue - leading to bleeding after removal.From the information provided, and no sample returned, a root cause cannot be reliably determined.The product has not undergone any design change that would affect its function in the previous two years.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.No re-training required.

Event Description

Update as per complaint intake form.Incident details surrounding event.The dr.Who is concerned about occasional trauma from lonestar hooks.He worries about patient tearing.After the procedure, the patient was bleeding when hooks were removed.The dr.Applied pressure with gauze to stop the bleeding which to my observation took a while.And now the doctor is afraid to use the product again due to that incident.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? yes.Medical or procedural intervention? yes.Patient/gamete/embryo status.Patient tearing during procedure and discomfort after procedure due to tearing when patient became conscious.Ref: 1216677-2022-00119 gynecology kit box of 5 - 3704 - (b)(4).

• Brand Name: 3704
• Type of Device: 3704
• 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: 14186438
• MDR Text Key: 297432064
• Report Number: 1216677-2022-00119
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: WA
• PMA/PMN Number: K791665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3704
• Device Catalogue Number: 3704
• Device Lot Number: 295175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other