PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-01739
- Event Type
- Injury
- Date Received
- February 23, 2024
- Report Date
- March 12, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. AN ATTEMPT HAS BEEN 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2020. HTTPS://DOI.ORG/10.1007/S11695-020-05091-1.
PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS?: CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE LITERATURE AND OTHER INFORMATION REQUESTED IS UNKNOWN.
TITLE: K-WIRE RETRACTOR, A TROCAR-FREE LIVER RETRACTION TECHNIQUE IN BARIATRIC SURGERY. THE AIM OF THIS STUDY IS TO ASSESS ITS EFFICACY AND SAFETY BY COMPARING IT WITH THE SUTURE-BASED RETRACTOR. A RETROSPECTIVE REVIEW WAS PERFORMED ON PATIENTS UNDERGOING LAPAROSCOPIC BARIATRIC SURGERY FROM (B)(6) 2016 TO (B)(6) 2019. A TOTAL OF 317 PATIENTS WERE INCLUDED IN OUR STUDY AND THERE WAS NO CONVERSION TO OPEN SURGERY. ALL PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE METHODS OF LIVER RETRACTION: THE K-WIRE RETRACTOR GROUP AND THE SUTURE-BASED RETRACTOR GROUP. IN K-WIRE RETRACTOR GROUP, THE SHARP END AND BLUNT END WAS INSERTED TO MAKE A PUNCTURE SITE TO THE ABDOMINAL WALL HEADING TOWARDS DIAPHRAGM. THE LEFT LOBE OF THE LIVER WAS LIFTED ANTERIORLY TO THE ABDOMINAL WALL BY A GRASPER. THE BLUNT END OF THE K-WIRE WAS DIRECTED UNDERNEATH THE LIFTED LIVER AND PLACED ON THE CRUS OF THE DIAPHRAGM. THE K-WIRE CAN PROVIDE SUFFICIENT LIVER RETRACTION AND OPTIMAL OPERATIVE FIELD. WITH THE ASSISTANCE OF A K-WIRE RETRACTOR, THE GASTROESOPHAGEAL JUNCTION AND GASTRIC FUNDUS WERE EXPOSED ADEQUATELY. AT THE END OF THE SURGERY, THE K- WIRE WAS REMOVED SAFELY UNDER LAPAROSCOPIC VISUALIZATION. THE PUNCTURE SITE WAS COVERED WITH A PIECE OF GAUZE. AND THE SUTURE BASED RETRACTOR GROUP, A 2¿0 PROLENE SUTURE WITH A 48 MM STRAIGHT NEEDLE WAS USED FOR LIVER SUSPENSION. THE LEFT LOBE OF THE LIVER WAS LIFTED, AND THE SUTURE WAS PLACED ACROSS THE RIGHT CRUS OF THE DIAPHRAGM. THE NEEDLE WAS THEN GUIDED OUT OF THE ABDOMINAL CAVITY, WITH THE SUTURE ANCHORED ONTO THE ABDOMINAL WALL. THE LIVER WOULD BE LIFTED BY THE SUTURE. THIS LIVER RETRACTION TECHNIQUE HAS BEEN EXTENSIVELY INVESTIGATED PREVIOUSLY. REPORTED COMPLICATION: LIVER HEMATOMA (N- 3). WOUND INFECTION: (N-2). CONCLUSION: THE K-WIRE RETRACTOR, A TROCAR-FREE LIVER RETRACTION TECHNIQUE IN BARIATRIC SURGERY PROVIDES A BETTER OPERATIVE FIELD AND IS ALSO SUITABLE FOR PATIENTS WITH BMI = 50 KG/M2 , WHICH COULD BE PLACED EASILY WHEN COMPARED WITH A SUTURE-BASED RETRACTOR. THEREFORE, IT HAS THE POTENTIAL TO SERVE AS A ROUTINE LIVER RETRACTOR IN BARIATRIC SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113209 | PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |