MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB; STAPLE, BIOABSORBABLE

Model Number	2030
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2: foreign: south africa, device location is unknown.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 caesarean section delivery on (b)(6) 2024 in which the insorb staples were used.Patient was checked eight hours post-op and found to be fine with no bleeding.Patient was mobilized at ten hours post-op and the entire wound opened up as if there was nothing holding the wound closed at all.Doctor had to close the wound again with vicryl suture and there was no staples holding the wound together.No additional information available.2030 insorb (b)(4).
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured by csi on 10/22/2024.Manufacturing record review: dhr-619049893 was reviewed and no non-conformities, related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions where the staplers erupted after surgery.However, there have been cases were wound separation is reported.Product receipt: the complaint product was not available at the time of this investigation.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 be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: no definitive root cause for this issue could be reliably determined.The ifu makes reference to the normal absorption time of the stapler as 10-12 weeks for one-half of its original mass, it also mentions the necessity of deep supporting sutures to ensure closure integrity and recommendations to minimize superficial or external staple placements.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
No additional information.

• Brand Name: INSORB
• Common Device Name: STAPLE, BIOABSORBABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 21265426
• Report Number: 1216677-2025-00005
• Device Sequence Number: 11831137
• Product Code: GDW
• UDI-Device Identifier: 00867516000104
• UDI-Public: (01)00867516000104(10)619049893(17)260830
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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 Expiration Date: 08/30/2026
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619049893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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