PWRD 25MM CURVED CIRCULAR, 18CM SHAFT
Report
- Report Number
- 3005075853-2024-09133
- Event Type
- Injury
- Date Received
- December 5, 2024
- Date of Event
- November 28, 2024
- Report Date
- February 7, 2025
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K163523
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). DATE SENT: 12/10/2024. ADDITIONAL EVENT INFORMATION: ·LEAK SITE IS AROUND THE POSTERIOR WALL OF THE INTESTINE, BUT IT IS NOT EXACTLY CLEAR. ·THE DOUGHNUT TISSUE SEEMS TO BE A LITTLE THIN ON THE ANORECTAL SIDE. ·THE PATIENT IS STILL HOSPITALIZED, BUT THE PATIENT'S CONDITION SEEMS TO BE STABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY? IT WAS ON LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. WHAT SURGICAL PROCEDURE WAS PERFORMED? IT WAS ON LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. DID THE PATIENT RECEIVE ANY PREOPERATIVE CHEMOTHERAPY OR RADIATION/? CURRENTLY, UNKNOWN. WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? THE DEVICE COULD NOT BE FIRED. WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? CURRENTLY, UNKNOWN. WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? CURRENTLY, UNKNOWN. DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? CURRENTLY, UNKNOWN. WHEN THE BATTERY WAS INSERTED WAS THE BACK LIGHT CONFIRMED TO BE ILLUMINATED? CURRENTLY, UNKNOWN. WERE THERE ANY ISSUES WITH DEVICE USE/FIRING? THE DEVICE COULD NOT BE FIRED. WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE COMPLETED THE FIRING SEQUENCE? CURRENTLY, UNKNOWN. WAS THE GREEN CHECKMARK VISIBLE AT THE END OF THE FIRING?CURRENTLY, UNKNOWN. HOW MANY COUNTER-CLOCKWISE REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? CURRENTLY, UNKNOWN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE? NO. WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? THE LEAK LOCATION WAS NOT PRECISELY CONFIRMED AROUND THE POSTERIOR WALL OF THE INTESTINE. THE DONUT TISSUE SEEMED TO BE A LITTLE THINNER ON THE ANAL SIDE. WERE THE DONUTS INSPECTED? THE LEAK LOCATION WAS NOT PRECISELY CONFIRMED AROUND THE POSTERIOR WALL OF THE INTESTINE. THE DONUT TISSUE SEEMED TO BE A LITTLE THINNER ON THE ANAL SIDE. IF SO, PLEASE DESCRIBE. THE LEAK LOCATION WAS NOT PRECISELY CONFIRMED AROUND THE POSTERIOR WALL OF THE INTESTINE. THE DONUT TISSUE SEEMED TO BE A LITTLE THINNER ON THE ANAL SIDE. WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION? LEAK WAS OCCURED. IF SO, PLEASE DESCRIBE THE SHAPE AND LOCATION. THE LEAK LOCATION WAS NOT PRECISELY CONFIRMED AROUND THE POSTERIOR WALL OF THE INTESTINE. THE DONUT TISSUE SEEMED TO BE A LITTLE THINNER ON THE ANAL SIDE. DOES THE SURGEON BELIEVE THE POST-OPERATIVE COMPLICATIONS WERE RELATED TO AN ALLEGED DEFICIENCY OF THE DEVICE OR WERE THERE OTHER CONTRIBUTING FACTORS TO INCLUDE PATIENT TISSUE CONDITION? CURRENTLY, UNKNOWN. WHAT TYPE OF LEAK TEST WAS PERFORMED? CURRENTLY, UNKNOWN. WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? THE DONUT TISSUE SEEMED TO BE A LITTLE THINNER ON THE ANAL SIDE.
(B)(4). DATE SENT 12/4/2024. D4 BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6: HEALTH EFFECT ¿ CLINICAL CODE GASTROINTESTINAL SYSTEM (E10). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHAT WERE THE INDICATIONS FOR SURGERY? WHAT SURGICAL PROCEDURE WAS PERFORMED? DID THE PATIENT RECEIVE ANY PREOPERATIVE CHEMOTHERAPY OR RADIATION? WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? WERE THERE ANY ISSUES WITH DEVICE USE/FIRING? WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE COMPLETED THE FIRING SEQUENCE? WAS THE GREEN CHECKMARK VISIBLE AT THE END OF THE FIRING? HOW MANY COUNTER-CLOCKWISE REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE? WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION? IF SO, PLEASE DESCRIBE THE SHAPE AND LOCATION. DOES THE SURGEON BELIEVE THE POST-OPERATIVE COMPLICATIONS WERE RELATED TO AN ALLEGED DEFICIENCY OF THE DEVICE OR WERE THERE OTHER CONTRIBUTING FACTORS TO INCLUDE PATIENT TISSUE CONDITION? WHAT TYPE OF LEAK TEST WAS PERFORMED? WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
(B)(4). DATE SENT: 2/7/2025 D4 BATCH # 520C52. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CDH25P DEVICE ARRIVED WITH NO APPARENT DAMAGE WITH A BATTERY INSERTED AND ALONG WITH A TYVEK. THE BATTERY WAS RETURNED DRAINED AND WITH A THE BREAKAWAY WASHER WAS PRESENT AND UNCUT, WHITE STAIN IN THE LEFT BATTERY TERMINAL. THE DEVICE WAS FULLY LOADED WITH STAPLES. WHEN THE BATTERY WAS INSTALLED, THE GREEN CHECKMARK DOES NOT ILLUMINATE, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED. DURING THE FUNCTIONAL TEST, AN ATTEMPT TO FIRE THE DEVICE THROUGHOUT THE FIRING RANGE WAS UNSUCCESSFUL. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE WELD IN POINT 01 ON FIRE BOARD WAS FOUND MISSING. ADDITIONALLY, A PHOTO WAS PROVIDED AT PRODUCT COMPLAINT LEVEL AND IT SHOWS THE DEVICE ALONG WITH A BATTERY AND NO APPARENT DAMAGE. THE WELD MISSING OBSERVED IS POTENTIALLY RELATED TO A MANUFACTURING PROCESS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON ENDO SURGERY¿S QUALITY SYSTEM. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 520C52, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.
(B)(4). DATE SENT 12/18/2024. CORRECTED DATA D4: UDI#. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
(B)(4). DATE SENT 1/2/2025. D4 BATCH #520C52. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE CDH25P DEVICE ARRIVED WITH NO APPARENT DAMAGE WITH A BATTERY INSERTED AND ALONG WITH A TYVEK. THE BATTERY WAS RETURNED DRAINED AND WITH A THE BREAKAWAY WASHER WAS PRESENT AND UNCUT, WHITE STAIN IN THE LEFT BATTERY TERMINAL. THE DEVICE WAS FULLY LOADED WITH STAPLES. WHEN THE BATTERY WAS INSTALLED THE GREEN CHECKMARK DOES NOT ILLUMINATE, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED. DURING THE FUNCTIONAL TEST, AN ATTEMPT TO FIRE THE DEVICE THROUGHOUT THE FIRING RANGE WAS UNSUCCESSFUL. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND AND THE WELD IN POINT 01 ON FIRE BOARD WAS FOUND MISSING. ADDITIONALLY, A PHOTO WAS PROVIDED AT PRODUCT COMPLAINT LEVEL AND IT SHOWS THE DEVICE ALONG WITH A BATTERY AND NO APPARENT DAMAGE. THE WELD MISSING OBSERVED IS POTENTIALLY RELATED TO A MANUFACTURING PROCESS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A PRODUCT ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH ETHICON ENDO SURGERY¿S QUALITY SYSTEM. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 520C52, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED.
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOIDECTOMY, THE DEVICE WAS USED IN THE USUAL STEPS, BUT IT DID NOT WORK EVEN THE FIRING TRIGGER WAS PULLED. THE ANVIL OF THE DEVICE IN QUESTION WAS PLACED AS IS, THE DEVICE WAS REPLACED WITH A NEW ONE AND IT COULD BE FIRED, BUT AN AIR LEAK OCCURRED. ADDITIONAL PROCEDURES BY THIS CASE WERE A 2 CENTIMETERS EXTENSION OF THE SKIN INCISION (EXTENSION OF THE SMALL INCISION WOUND WHEN REMOVING THE DOCKING OF THE ANVIL AND DEVICE BY HAND), AS WELL AS THE PLACEMENT OF A COVERING STOMA (EXTENDED THE OPERATION TIME FOR 1 HOUR). ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2096144 | PWRD 25MM CURVED CIRCULAR, 18CM SHAFT | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | 520C52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |