MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Hernia (2240)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength = 2360 ¿g/m.(b)(4).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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to clarify 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 ethicon product (stratafix suture- unknown type) involved caused and/or contributed to post-operative complications (pain, infection, urinary retention and hernia recurrence) described in the article? please specify.Does the surgeon believe there was any deficiency with the ethicon product (prolene mesh and stratafix suture) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (pain, infection, urinary retention and hernia recurrence).Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Please specify what type of stratafix suture or product code/lot number was used in these cases.Citation:journal of robotic surgery (2018) 12:699¿704 https://doi.Org/10.1007/s11701-018-0812-7.

Event Description

Title: first 100 consecutive robotic inguinal hernia repairs at a veterans affairs hospital a retrospective review of the first 100 consecutive robotic inguinal hernia repairs was conducted by collecting patient data available in the va computerized patient record system (cprs).Data from a contemporaneous series of 100 consecutive open inguinal hernia repairs was also collected from cprs to use as a comparison group.Comparative pain scale scores (scale 0¿10) were recorded in the pre-operative holding area on the day of surgery (pre-op), in the post-anesthesia care unit (pacu), on post-operative day (pod1) and on the first post-operative follow-up visit.Robotic inguinal hernia repair was performed via a transabdominal approach (tapp) with either a four-arm or three-arm robotic technique on the davinci xi dual console system.Dissection is performed with the monopolar scissors in the right hand, the bipolar fenestrated grasper in the left hand, and the tip-up fenestrated grasper in the lateral most accessory port.The tip up fenestrated grasper retracted the peritoneum and was repositioned as necessary throughout the case.Once the hernia is reduced and the myopectineal orifice completely exposed, mesh is introduced and positioned for tension-free hernioplasty.The peritoneal flap is closed using 3-0 stratfix suture (ethicon).Open hernia repairs were performed via prolene mesh (ethicon), 0.25% bupivacaine or a 1:1 mix of 1% lidocaine and 0.25% bupivacaine was used prior to making incision.Reported complications included in robot inguinal hernia repair pacu (1.5), infection (n=3), urinary retention (n=18), hernia recurrence (n=4).In open hernia repairs pacu (n=1), pain pod1 (n=2), multiple post-op visits for pain (n=9), infection (n=7), urinary retention (n=13), testes injury (n=1), nerve injury (n=1) and hernia recurrence (n=4).In conclusion outcomes comparable to oihr can be achieved with rihr in the va system.Complex patients and complex hernias can be treated safely and efficiently with the robotic approach.For select patients, rihr offers less pain in the early post-op period than oihr.Improvements in operative technique can help decrease operative times in rihr.

• Brand Name: STRATAFIX SYMMETRIC PDS
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11632221
• MDR Text Key: 261234789
• Report Number: 2210968-2021-03131
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1