MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE TRIAD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	FORCETRIADZE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Disseminated Intravascular Coagulation (DIC) (1813); Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	01/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the literature source study, presenting the experience with surgical management of placenta praevia percreta.A total of 58 patients underwent ultrasound mapping of the placental area before surgery.Cesarean section delivery was performed for percreta patients over the 34th week of gestation if no other emergent situation (bleeding, uterine contraction, membrane rupture) was present.Four patients (6.9 %) had bladder injury as a result of dense adhesions between the posterior wall of the bladder and uterus during dissection.All these injury cases are managed together with expert urologist.One patient (1.7 %) required cystotomy, and one patient (1.7 %) required re-operation because of postoperative hemorrhage.Four patients (6.9%) had disseminated intravascular coagulation (dic), two patients (3.4%) had pulmonary embolism and four patients (6.9%) with wound infection.

• Brand Name: FORCE TRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8150400
• Report Number: 1717344-2018-01610
• Device Sequence Number: 10830029
• Product Code: GEI
• UDI-Device Identifier: 10884521133310
• UDI-Public: 10884521133310
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FORCETRIADZE
• Device Catalogue Number: FORCETRIADZE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR