MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB 30 STAPLER; SKIN STAPLER/STAPLE, BIOABSORBABLE

Model Number	2030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has indicated that the product will not be returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a caesarian section procedure on (b((6) 2023.Doctor states that the staples keep coming up through the surface of the skin and need to be removed.Patient incurred massive infection as well as two trips to the er.Doctor inquired as to the staple absorption time.No additional information is available.1216677-2023-00159 2030 insorb stapler (b)(4).
Additional Manufacturer Narrative
Distribution history: the lot number was not provided for this complaint, no information of distribution history could be performed.Manufacturing record review: the lot number was not provided for this complaint, no information of manufacturing record could be performed.Incoming inspection review: the lot number was not provided for this complaint, no information of incoming inspection could be performed.Service history record : service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history related to infection shows 10 similar reported complaints including the one under investigation.None of the complaints reviewed were confirmed.Product receipt: the complaint product was not returned.Visual evaluation: the complaint product was not returned, no visual inspection could be performed.Functional evaluation : the complaint product was not returned, no functional inspection could be performed.However one box of the lots that were bought by the customer still in coopermedical distribution center, the lot 619022984.The lot was functionally reviewed and the (b)(4) units passed the acceptance criteria.Root cause : not enough information to define a root cause for this complaint, the units reviewed were not necessarily the lot that the customer used during the medical procedure.Coopersurgical will continue to monitor this complaint condition for trends.No corrective action is determined since the complaint is not confirmed.
Event or Problem Description
No additional information is available.
Event or Problem Description
No additional information.

• Brand Name: INSORB 30 STAPLER
• Common Device Name: SKIN STAPLER/STAPLE, BIOABSORBABLE
• 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 ; 4752651582
• MDR Report Key: 18324951
• Report Number: 1216677-2023-00159
• Device Sequence Number: 17912672
• Product Code: GDW
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/26/2024; 10/25/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/01/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female