MAUDE Adverse Event Report: STRYKER GMBH KNIFE LIGHT 10/PK; SURGICAL LAMP

Catalog Number 3300-001-000

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital policy.

Event Description

It was reported that during surgery, the taller edge of the knifelight that protects the knife broke off in the patient.Rep was not present for procedure.Surgeon reported the piece was retrieved from the patient and that he feels he applied too much pressure.Surgeon indicated there was no patient harm and no allegation against the device.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: KNIFE LIGHT 10/PK
• Type of Device: SURGICAL LAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER ENDOSCOPY-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8030791
• MDR Text Key: 126504637
• Report Number: 0008031020-2018-00942
• Device Sequence Number: 0
• Product Code: FTD
• Reporter Country Code: US
• PMA/PMN Number: K961122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3300-001-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 89