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

Model Number	MS101008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while the device was being applied to the abdominal wall during catheter insertion in a laparoscopic procedure, the cannula broke.The surgeon inserted the needle into the radially expandable sleeve after insufflation.The sleeve and needle were inserted normally into the patient to deploy the sleeve, but the sleeve essentially was stuck to the needle and buckled or bunched up as the surgeon attempted to remove the needle.They tried using 2 other units of same device but similar sticking malfunction occurred.They used another device to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of eight devices.A visual inspection of the returned product noted: two expandable sleeves were cut and the protective sheath was disengaged.The other six appeared intact.The trocars, cannulas, obturators, circular and envelope seals appeared intact.A functional evaluation found that the devices passed an air leak test.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut expandable sleeves may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while the device was being applied to the abdominal wall during catheter insertion in a laparoscopic procedure, the cannula broke.The surgeon inserted the needle into the radially expandable sleeve after insufflation.The sleeve and needle were inserted normally into the patient to deploy the sleeve, but the sleeve essentially was stuck to the needle and buckled or bunched up as the surgeon attempted to remove the needle.They tried using two other units of the same lot but similar sticking malfunction occurred.They used another device of the same lot to complete the procedure.There was no patient injury.

• Brand Name: MINI 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: 8067908
• Report Number: 2647580-2018-05503
• Device Sequence Number: 19364221
• Product Code: GCJ
• UDI-Device Identifier: 20884521082745
• UDI-Public: 20884521082745
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2019

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: 04/30/2021
• Device Model Number: MS101008
• Device Catalogue Number: MS101008
• Device Lot Number: P8D1297X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 04/16/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/05/2019; 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1