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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number UNKNOWN LAPRO-CLIP RELOAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Internal Organ Perforation (1987)
Event Date 11/07/2016
Event Type  Injury  
Manufacturer Narrative

Title: evaluation of relative criteria for single-incision laparoscopic cholecystectomy source: department of surgery, kansai medical university, osaka, japan date: received 25 august 2016; received in revised form 13 october 2016; accepted 7 november 2016 available online 5 december 2016. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature article evaluation of relative criteria for sils (single-incision laparoscopic cholecystectomy), by yoichi matsui*, so yamaki, satoshi hirooka, tomohisa yamamoto, hiroaki yanagimoto, sohei satoi, masanori kon, published august 25, 2016, the aim of this study was to evaluate the suitability of our criteria for single-incision laparoscopic cholecystectomy (silc). 1093 patients underwent conventional laparoscopic cholecystectomy (lc), and 232 (21. 2%) of these patients underwent silc. Clip appliers were used to ligate the cystic duct and artery in patients who underwent single incision laparoscopic cholecystectomy. Sils port and retractor external diameter were used. Fourteen (6. 0%) patients required additional laparoscopic ports for silc. Reasons for the additional ports included failure to adequately expose the calot triangle secondary to unexpected extensive adhesions, insufficient views, and bleeding. Intraoperative gallbladder rupture with bile spillage occurred in 21 (9. 1%) patients during silc.

 
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Brand NameLAPRO-CLIP
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer (Section G)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8318205
MDR Text Key135501342
Report Number1219930-2019-00767
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 02/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN LAPRO-CLIP RELOAD
Device Catalogue NumberUNKNOWN LAPRO-CLIP RELOAD
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/07/2019 Patient Sequence Number: 1
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