MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK CLIP

Catalog Number SURGICAL UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Alleged event: the patient underwent robotic assist right partial nephrectomy.During pacu stay, the patient became significantly hypotensive with dropping hemoglobin and hematocrit.After fluid resuscitation and blood administration, the patient remained unstable and returned to surgery for exploration.Upon review it appears that the lapra-ty came loose from the vessel causing the hem-o-lok to also come off.This accounted for the large post-operative bleed.Nothing in the original surgery was out of the ordinary.The area was assessed before closure and was dry and stable.The following statement was reported: patient will suffer no further complications.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).This submission is in reference to (b)(4).The device history review could not be conducted since the lot number was not provided.The manufacturer will continue to monitor and trend related events.

• Brand Name: HEM-O-LOK CLIP
• Type of Device: HEM-O-LOK CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 2147 8; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4929871
• MDR Text Key: 6055237
• Report Number: 3003898360-2015-00497
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SURGICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1