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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Hernia (2240)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Device not returned. 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 (prolene mesh) involved caused and/or contributed to post-operative complications (pain, infection, urinary retention, testes injury, nerve injury 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, testes injury, nerve injury and hernia recurrence). Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Please provide what product code/lot number of prolene mesh was used in these cases. Citation:journal of robotic surgery (2018) 12:699¿704 https://doi. Org/10. 1007/s11701-018-0812-7. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Events were submitted 2210968-2021-03131.
 
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.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key11632222
MDR Text Key261422508
Report Number2210968-2021-03130
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial
Removal/Correction NumberN/A

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