MAUDE Adverse Event Report: MEDLINE RENEWAL STRYKER; SERFAS ENERGY 90-S, 90 DEGREE SUCTION PROBE, W/INTEGRATED CORD, (GREY) 3.5MM SER

Catalog Number 279351100RH

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of the reprocessed stryker serfas wand (serfas energy 90-s, 90 degree suction probe, with integrated cord, (grey) 3.5mm) broke and fell into the surgical site.Per report, the broken device tip was successfully retrieved from the patient using an unidentified device.A new serfas wand was reportedly opened and the procedure was finished without further incident.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to this incident.Due to the reported event and required medical intervention to retrieve the device tip from the surgical site, this medwatch is being filed.The device was returned for evaluation and the complaint was confirmed.A review of the reprocessing records was performed and indicated that all processes were conducted as required.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the reprocessed stryker serfas wand broke off into surgical site.

• Brand Name: STRYKER
• Type of Device: SERFAS ENERGY 90-S, 90 DEGREE SUCTION PROBE, W/INTEGRATED CORD, (GREY) 3.5MM SER
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8478343
• MDR Text Key: 141075254
• Report Number: 3032391-2019-00005
• Device Sequence Number: 0
• Product Code: NUJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279351100RH
• Device Lot Number: 382667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 152