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

Model Number 2030

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that staples are not staying in or absorbing.No additional information is available.No adverse event reported.2030 insorb stapler 2023-06-0000599.

Manufacturer Narrative

Customer has indicated that the product is in process of being returned to cooper surgical for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Distribution history the complaint product was manufactured at csi on december 2nd, 2022 under work order (b)(4).Manufacturing record review dhr of lot 619019341 was reviewed and no non-conformities, related to the complaint condition, were noted.Also the dhr from the staple lot 326856 were checked and no non-conformities were found.Incoming inspection review iqc was reviewed and no non-conformities, related to the complaint condition, were noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history related to not firing shows 16 similar reported complaints including the one under investigation.None of the complaints reviewed were confirmed.Product receipt the complaint product was returned and reviewed by quality engineer, details will be provided on visual and functional evaluation sections.Visual evaluation the unit that presented the issue according to the customer was not returned for evaluation, however the customer sent units without use, it was received 5 units of lot 619019341, 3 units of lot 619018836 and 6 units of lot 619019342.Visual evaluation of the units received was performed, but no abnormal conditions were found.Functional evaluation of the units received were performed, units were tested against inspection measurements, all units passed the acceptance criteria.Root cause: no definitive root cause for this issue could be reliably determined at this time because the product was not returned for evaluation, additional samples sent by the customer did not present any issues related to manufacturing process.Corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.

Event Description

No additional information is available.

• Brand Name: INSORB 30 STAPLER
• Type of Device: SKIN STAPLER/STAPLE, BIOABSORBABLE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 17349754
• MDR Text Key: 320148916
• Report Number: 1216677-2023-00104
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 867516000104
• UDI-Public: (01)867516000104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2030
• Device Catalogue Number: 2030
• Device Lot Number: 619019341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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