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

Model Number 2020

Device Problem Mechanical Problem (1384)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

Details of the complaint: "not firing correctly." "the staplers were used on 3 separate patients with no negative effects.We were able to complete the closure with traditional suture closure.We did have a short delay of approximately 10 minutes on each case." 1216677-2022-00327 insorb 30 stapler 2030 e-complaint-(b)(4).

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

Manufacturer Narrative

Investigation: no sample returned review dhr *analysis and findings distribution history the complaint product was manufactured at csi on june 07th, 2022 under work order (b)(4).Manufacturing record review dhr cr_dhr_2030_619010362 was reviewed and no non-conformities, related to the complaint condition, were noted.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 did show similar reported complaint conditions.Similar issues were found also for other insorb codes related to does not perform properly.On the complaints reviewed the complaint condition could not be confirmed as the product was not returned for evaluation.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation visual evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.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 because the product was not returned for evaluation.*correction and/or 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.Not training required for this complaint.*was the complaint confirmed? no.

Event Description

Not firing correctly."we were able to complete the closure with traditional suture closure.We did have a short delay of approximately 10 minutes on each case." 1216677-2022-00327-1 insorb 30 stapler 2030 (b)(4).

• Brand Name: INSORB 30 STAPLER
• Type of Device: INSORB 30 STAPLER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16050612
• MDR Text Key: 306909163
• Report Number: 1216677-2022-00327
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 00867516000104
• UDI-Public: 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2020
• Device Catalogue Number: 2030
• Device Lot Number: 619010362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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
• Patient Outcome(s): Other