MAUDE Adverse Event Report: COOPERSURGICAL, INC. INSORB 30 STAPLER; INSORB SUBCUTICULAR SKIN STAPLER

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to an allergist due to an unknown reaction after having a c-section procedure.Attempts have been made, but no additional information has been provided.2030 insorb 2024-10-0000224.
Additional Manufacturer Narrative
Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Distribution history the product was manufactured by csi.Manufacturing record review a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, and this complaint amended accordingly.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions.In those cases, there was no reliable way to correlate the infection to the use of the insorb stapler.Product receipt the complaint product has not been returned to csi.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 at this time.However, insorb staples are made of an absorbable copolymer of polyglycolic/polylactic acid (plga) which is a synthetic polyester derived from lactic and glycolic acids.Pla degrades to form lactic acid which is normally present in the body and its metabolism in the body is well characterized, with water and carbon dioxide as the final metabolites.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action in necessary, as the complaint condition was not confirmed.

• Brand Name: INSORB 30 STAPLER
• Common Device Name: INSORB SUBCUTICULAR SKIN STAPLER
• 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: 20582663
• Report Number: 1216677-2024-00061
• Device Sequence Number: 15597144
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female