3MM ELASTIC STAYS 8/PK
Report
- Report Number
- 1216677-2024-00057
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- July 29, 2024
- Report Date
- June 19, 2025
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- GAD
- UDI-DI
- 00888937015508
- PMA / PMN Number
- K791665
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G2: UK DEVICE WAS DISCARDED BY HOSPITAL DUE TO CONTAMINATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
UPDATED: B4, G3, G6, H2, H3, H11. CORRECTED: B1, B2, H6. THE COMPLAINT INVESTIGATION HAS NOT CHANGED. SUPPLEMENTAL SUBMISSION IS TO CORRECT THE CODES FOR HEALTH IMPACT (F) AND INVESTIGATION CONCLUSION (D). COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IN NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.
DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 15 MAY 2023. MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. HISTORIC COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. 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 AS THERE IS NO PRODUCT NOR PICTURES AVAILABLE FOR EVALUATION/VERIFICATION. THE DHR REVIEW SHOWED THAT A AQL SAMPLING QUALITY INSPECTION PULL TEST WAS PERFORMED AND PASSED FOR LOT 334241. NO FURTHER INVESTIGATION COULD BE PERFORMED WITH THE INFORMATION AVAILABLE FOR THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTIONS REQUIRED AS THE COMPLAINT CONDITION WAS NOT CONFIRMED, COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED PAN-PROCTOCOLECTOMY, A LONE STAR RETRACTOR AND ELASTIC STAYS WERE USED AS RETRACTION DURING THE PROCEDURE. WHEN REMOVING THE DEVICE, IT WAS NOTICED THAT ONE OF THE HOOKS HAD BECOME DETACHED FROM THE SURGICAL STAY AND ANOTHER WAS BENDING. THEREFORE THE RETRACTORS AND STAYS WERE REMOVED AND A SEARCH OF THE AREA AND PATIENT WAS PERFORMED TO LOCATE THE MISSING HOOK. A SPECIMEN X-RAY WAS PERFORMED IN THEATRE. IT WAS ESTABLISHED THAT THE HOOK WAS NOT IN THE PATIENT. .3314-8G 3MM ELASTIC STAYS 2024-09-0000206.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1371728 | 3MM ELASTIC STAYS 8/PK | SURGICAL RETRACTOR | GAD | COOPERSURGICAL, INC. | 3314-8G | 334241 | 00888937015508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |