MAUDE Adverse Event Report: US SURGICAL (INACTIVE) SILS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SILSCLINCH36
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.The visual inspection of the device noted no visual abnormalities.The handle function did not close the jaws.The device rotated and the shaft could be locked in place.Upon disassembling the device, it was noted that the cable that operates the jaws was broken and disengaged.Product analysis suggests the product was used in a surgical procedure.The reported condition was not confirmed.A secondary condition of broken cable was noted.The most probable root cause of the broken cable may be due to rough handling of the device.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Event or Problem Description
According to reporter during a lap hysterectomy procedure the handpiece was visibly broken when opened from packaging and unable to be used.No additional operating time.No additional blood loss.No adverse effect to patient.No tissue damage or unanticipated tissue loss, opened up another hand piece and there was no issue.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SILS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL (INACTIVE); 60 middletown ave; north haven CT 06473
• MDR Report Key: 6633547
• Report Number: 1219930-2017-05757
• Device Sequence Number: 10766935
• Product Code: GCJ
• UDI-Device Identifier: 20884523000587
• UDI-Public: 20884523000587
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K091869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SILSCLINCH36
• Device Catalogue Number: SILSCLINCH36
• Device Lot Number: N6G0591X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1