MAUDE Adverse Event Report: US SURGICAL PUERTO RICO STEP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	S101010
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Codes	Tissue Damage (2104); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
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 reporter, during total laparoscopic hysterectomy, upon trocar insertion, the inferior portion of the trocar broke off and fell into the abdomen and was retrieved using cryo or kelly clamps and addisons.It was mentioned that there was tissue damage (bruising) from retrieving the portions that broke off from the trocar.It was noted that they were able to remove all the fragments from the patient as far as they knew.The surgical time extended 30 minutes or more due to the product problem which was spent retrieving the lost piece of the trocar, opening new supplies, and cleaning up debris from the trocar upon closing.It was also noted that the incision was extended due to the product problem but not more than 1 inch.Another trocar was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the trocar and cannula were only received.The cannula was broken in two pieces.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the bent needles may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8448399
• Report Number: 2647580-2019-01576
• Device Sequence Number: 18921017
• Product Code: GCJ
• UDI-Device Identifier: 20884521090764
• UDI-Public: 20884521090764
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K961940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: S101010
• Device Catalogue Number: S101010
• Device Lot Number: P8J1163X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 91