INSORB 30 STAPLER
Report
- Report Number
- 1216677-2023-00146
- Event Type
- Injury
- Date Received
- November 1, 2023
- Date of Event
- October 17, 2023
- Report Date
- November 12, 2024
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- GDW
- UDI-DI
- 00867516000104
- PMA / PMN Number
- K120373
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
DISTRIBUTION HISTORY: THE LOT NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT, NO INFORMATION OF DISTRIBUTION HISTORY COULD BE PERFORMED. MANUFACTURING RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT, NO INFORMATION OF DISTRIBUTION HISTORY COULD BE PERFORMED. INCOMING INSPECTION REVIEW: THE LOT NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT, NO INFORMATION OF DISTRIBUTION HISTORY COULD BE PERFORMED. SERVICE HISTORY RECORD : SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY RELATED TO "INFECTION" SHOWS 9 SIMILAR REPORTED COMPLAINTS INCLUDING THE ONE UNDER INVESTIGATION. NONE OF THE COMPLAINTS REVIEWED WERE CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS NOT RETURNED. VISUAL EVALUATION: THE COMPLAINT PRODUCT WAS NOT RETURNED, NO VISUAL INSPECTION COULD BE PERFORMED. FUNCTIONAL EVALUATION: THE COMPLAINT PRODUCT WAS NOT RETURNED, NO FUNCTIONAL INSPECTION COULD BE PERFORMED. ROOT CAUSE: NOT ENOUGH INFORMATION TO DEFINE A ROOT CAUSE FOR THIS COMPLAINT, HOWEVER THE SURGICAL REPRESENTATIVE REACHED THE L&D DIRECTOR OF THE HOSPITAL AND THEY DO NOT BELIEVE THAT INSORB WAS THE CAUSAL FACTOR IN THESE CASES.
UPDATED: B4, D2B, D4, G3, G6, H2, H11. CORRECTION: G1. NO CHANGE TO THE FINAL INVESTIGATION FINDINGS. UPDATING THE UDI NUMBER. CORRECTION TO EMAIL CONTACT.
CASE 1/8. HOSPITAL HAS REPORTED AN INVESTIGATION INTO AN INCREASED RATE OF SURGICAL SITE INFECTIONS (SSI) RELATED TO CAESAREAN SECTIONS. IT WAS REPORTED THAT 8 RECENT CASES, ALL INSORB C-SECTION CLOSURES, RESULTED IN SSI'S. MAJORITY OF DOCTORS USE THE INSORB STAPLER FOR C-SECTIONS. THIS WAS A NOTICEABLE UPTICK IN DEPARTMENT INFECTION RATE. AFTER INVESTIGATION, THE HOSPITAL DOES NOT BELIEVE THAT THE INSORB STAPLER WAS THE CAUSAL FACTOR IN THESE CASES. RATHER, THEY BELIEVE THAT THE ISSUES STEM FROM LAPSES IN STERILITY AND INFECTION CONTROL MEASURES AS PRACTICED BY THEIR STAFF. HOSPITAL IS CORRECTING THROUGH RE-EDUCATION AND ENHANCED GUIDELINES. STAPLERS ARE NOT BEING RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE. 2030 INSORB STAPLER 2023-10-0000418.
NO ADDITIONAL INFORMATION IS AVAILABLE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2033540 | INSORB 30 STAPLER | SKIN STAPLER/STAPLE, BIOABSORBABLE | GDW | COOPERSURGICAL, INC. | 2030 | UNKNOWN | 00867516000104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |