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

Model Number	2030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Case 6/8 hospital has reported an investigation into an increased rate of surgical site infections (ssi) related to caesarean sections.It was reported that 8 recent cases, all insorb c-section closures, resulted in ssi's.Majority of doctors use the insorb stapler for c-sections.This was a noticeable uptick in department infection rate.After investigation, the hospital does not believe that the insorb stapler was the causal factor in these cases.Rather, they believe that the issues stem from lapses in sterility and infection control measures as practiced by their staff.Hospital is correcting through re-education and enhanced guidelines.Staplers are not being returned.No additional information is available.2030 insorb stapler 2023-10-0000423.
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.
Additional Manufacturer Narrative
Updated: b4, g3, g6, h2, h3, h6, h10 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 distribution history could be performed.Incoming inspection review the lot number was not provided for this complaint, no information of distribution history 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 9 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.Root cause not enough information to define a root cause for this complaint, however the surgical representative reached the l&d director of the hospital and they do not believe that insorb was the causal factor in these cases.
Event or Problem Description
No additional information is available.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No change to the final investigation findings.Updating the udi number.Correction to email contact.

• 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: 18046877
• Report Number: 1216677-2023-00151
• Device Sequence Number: 8076908
• Product Code: GDW
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• 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): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 12/01/2023; 10/25/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 12/11/2023; 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
• Patient Sex: Female