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 09/25/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the condition reported.

Event Description

What are the details of the complaint? actually there have been 4 (two same gyn) separate incidents in the last two and half weeks that i was made aware of yesterday morning.I have already met with 3 of the physicians and will meet with one more tomorrow.Furthermore, i will not be able to provide any lot numbers for these insorb incidents where i was not in those particular cases.What procedure was the physician performing? unknown did the physician perform any extra step to complete the procedure? none reported.How is patient today? unknown.Was there any additional medical attention? unknown.Insorb 30 stapler 2030 e-complaint(b)(4).

Event Description

Rep reported: this morning i received a call from dr [ ] who stated that a patient that had insorb used on their c-section incision about 28 hours ago had all the staples open up and displace, leaving the incision wide open.Dr [ ] stated that it was really weird how the staples looked like they probably would after about 2-3 weeks post op.Insorb 30 stapler 2030 (b)(4).

Manufacturer Narrative

Investigation: review dhr inspect returned samples.Analysis and findings distribution history.The lot number of the products used are unknown however the customer sent back a sampling of their inventory.The complaint products were manufactured at csi.Manufacturing record review a specific lot number was not provided by the customer however, according to the sample sent: dhr-2030 - 619009267, dhr-2030 - 619009266, dhr-2030 - 619020360, dhr-2030 - 619009265, and dhr-2030 - 619003833, dhr-2030 - 619007795, dhr-2030 - 619008193, dhr-2030 - 619003118 were reviewed and no non-conformities, related to the complaint condition were noted.Incoming inspection review incoming inspection record review not applicable to this product.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history showed similar reported complaint conditions were the stapler stopped working.Product receipt the complaint products were returned on 10/05/22.The lot number of the returned products were: received lot number quantity 619009267 6 619009266 6 619010360 6 619009265 5 619003833 2 619007795 1 619008193 1 619003118 1.Visual evaluation packaging: all returned product was verified to have no breach to the sealed packaging.Seal condition: the returned product was verified to display a minimum 1/8 inch seal.Desiccant packs: the desiccant packs did not indicate prolonged exposure to moisture.Storage conditions: outer box with temperature indicator was not returned.Visual examination of the complaint products revealed no physical damage.Functional evaluation the complaint products were functionally evaluated and tested by the quality inspectors and a report was issued for every lot number provided (see attachments) and were found to function properly.In lot 619009265 one of the staplers presented 2 staples that failed the penetrator gap and staple measurements by 0.001 inch, but the rest were found to function properly.All the staplers were completely fired and found to function correctly.Root cause no definitive root cause for this issue could be reliably determined at this time as the faulty lot numbers were not provided.However, it is worth mentioning that the returned products tested to specification.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.*was the complaint confirmed? no.

• 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: 15477760
• MDR Text Key: 306179876
• Report Number: 1216677-2022-00266
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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