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

Model Number	OMS-T10BTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
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, during a laparoscopic ovarian cystectomy, while inflating the balloon, it popped.They opened a new product to complete the case.There was no patient injury.

• Brand Name: AUTO SUTURE
• 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: 7378852
• Report Number: 2647580-2018-01589
• Device Sequence Number: 1263885
• Product Code: GCJ
• UDI-Device Identifier: 10884521081079
• UDI-Public: 10884521081079
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K924011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 12/31/2019
• Device Model Number: OMS-T10BTS
• Device Catalogue Number: OMS-T10BTS
• Device Lot Number: P6M0588X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1