MAUDE Adverse Event Report: MEDTRONIC INC. RELIACATCH 10; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Lot Number C1121917A

Device Problem Break (1069)

Patient Problems Adhesion(s) (1695); Ectopic Pregnancy (1819); Thrombus (2101); No Code Available (3191)

Event Date 01/09/2020

Event Type  No Answer Provided  

Event Description

Specimen bag broke during procedure.Procedure: rso, op note: in the right lower quadrant, an 11-mm incision was made and an 11-mm port was placed under direct visualization.At this point using the scissors, the filmy adhesions were removed from the right side so that we could see the tube and the ovary, it was a complex mass.There did not appear to be much normal ovarian tissue, so grasping the ovary and pulling away from the sidewall using the ligasure, we came across the infundibulopelvic ligament and the adhesions of the ovary to the widewall.We then came across removing the tube and the uteroovarian ligament.It appeared that the ectopic pregnancy then was burst from the tube.There was a large amount of blood clot and this was then suctioned out through the suction.Once we had the tube ovary removed, we placed them in the bag, which was placed through the 11-mm port.The bag was then removed.In removing the first bag, only part of the specimen was removed and the bag broke.Therefore, a second bag was placed.Rest of the specimen was placed in this bag and then that was easily removed.The 11-mm port was then replaced.Once we replaced the port, we cleaned some adhesions from the left side as we could.We inspected all the pedicles and they were found to be dry.Copious amounts of irrigation were then used.At this point, it was elected to terminate the procedure.Fda safety report id# (b)(4).

• Brand Name: RELIACATCH 10
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 9601628
• MDR Text Key: 176020441
• Report Number: MW5092341
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Lot Number: C1121917A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 73